Method and system for control of osmotic pump device

ABSTRACT

Embodiments of a system including a remotely controlled osmotic pump device and associated controller are described. Methods of use and control of the device are also disclosed. According to some embodiments, an osmotic pump device is placed in an environment in order to pump a material into the environment or into an additional fluid handling structure within the osmotic pump device. Exemplary environments include a body of an organism, a body of water, or an enclosed volume of a fluid. In selected embodiments, a magnetic field, an electric field, or electromagnetic control signal may be used.

CROSS-REFERENCE TO RELATED APPLICATIONS

The present application is related to, claims the earliest availableeffective filing date(s) from (e.g., claims earliest available prioritydates for other than provisional patent applications; claims benefitsunder 35 USC § 119(e) for provisional patent applications), andincorporates by reference in its entirety all subject matter of thefollowing listed application(s) (the “Related Applications”) to theextent such subject matter is not inconsistent herewith; the presentapplication also claims the earliest available effective filing date(s)from, and also incorporates by reference in its entirety all subjectmatter of any and all parent, grandparent, great-grandparent, etc.applications of the Related Application(s) to the extent such subjectmatter is not inconsistent herewith. The United States Patent Office(USPTO) has published a notice to the effect that the USPTO's computerprograms require that patent applicants reference both a serial numberand indicate whether an application is a continuation or continuation inpart. The present applicant entity has provided below a specificreference to the application(s) from which priority is being claimed asrecited by statute. Applicant entity understands that the statute isunambiguous in its specific reference language and does not requireeither a serial number or any characterization such as “continuation” or“continuation-in-part.” Notwithstanding the foregoing, applicant entityunderstands that the USPTO's computer programs have certain data entryrequirements, and hence applicant entity is designating the presentapplication as a continuation in part of its parent applications, butexpressly points out that such designations are not to be construed inany way as any type of commentary and/or admission as to whether or notthe present application contains any new matter in addition to thematter of its parent application(s).

Related Applications

1. For purposes of the USPTO extra-statutory requirements, the presentapplication constitutes a continuation-in-part of U.S. patentapplication Ser. No. ______, entitled OSMOTIC PUMP WITH REMOTELYCONTROLLED OSMOTIC PRESSURE GENERATION, naming Leroy E. Hood, Muriel Y.Ishikawa, Edward K. Y. Jung, Robert Langer, Clarence T. Tegreene, LowellL. Wood, Jr. and Victoria Y. H. Wood as inventors, filed Dec. 13, 2005,which is currently co-pending, or is an application of which a currentlyco-pending application is entitled to the benefit of the filing date.

2. For purposes of the USPTO extra-statutory requirements, the presentapplication constitutes a continuation-in-part of U.S. patentapplication Ser. No. ______, entitled OSMOTIC PUMP WITH REMOTELYCONTROLLED OSMOTIC FLOW RATE, naming Leroy E. Hood, Muriel Y. Ishikawa,Edward K. Y. Jung, Robert Langer, Clarence T. Tegreene, Lowell L. Wood,Jr. and Victoria Y. H. Wood as inventors, filed Dec. 13, 2005, which iscurrently co-pending, or is an application of which a currentlyco-pending application is entitled to the benefit of the filing date.

3. For purposes of the USPTO extra-statutory requirements, the presentapplication constitutes a continuation-in-part of U.S. patentapplication Ser. No. ______, entitled REMOTE CONTROL OF OSMOTIC PUMPDEVICE, naming Leroy E. Hood, Muriel Y. Ishikawa, Edward K. Y. Jung,Robert Langer, Clarence T. Tegreene, Lowell L. Wood, Jr. and Victoria Y.H. Wood as inventors, filed Dec. 13, 2005, which is currentlyco-pending, or is an application of which a currently co-pendingapplication is entitled to the benefit of the filing date.

4. For purposes of the USPTO extra-statutory requirements, the presentapplication constitutes a continuation-in-part of U.S. patentapplication Ser. No. 11/272,524, entitled REMOTE CONTROLLED IN SITUREACTION DEVICE, naming Leroy E. Hood, Muriel Y. Ishikawa, Edward K. Y.Jung, Robert Langer, Clarence T. Tegreene, Lowell L. Wood, Jr. andVictoria Y. H. Wood as inventors, filed Nov. 9, 2005, which is currentlyco-pending, or is an application of which a currently co-pendingapplication is entitled to the benefit of the filing date.

5. For purposes of the USPTO extra-statutory requirements, the presentapplication constitutes a continuation-in-part of U.S. patentapplication Ser. No. 11/271,145, entitled REACTION DEVICE CONTROLLED BYMAGNETIC CONTROL SIGNAL, naming Leroy E. Hood, Muriel Y. Ishikawa,Edward K. Y. Jung, Robert Langer, Clarence T. Tegreene, Lowell L. Wood,Jr. and Victoria Y. H. Wood as inventors, filed Nov. 9, 2005, which iscurrently co-pending, or is an application of which a currentlyco-pending application is entitled to the benefit of the filing date.

6. For purposes of the USPTO extra-statutory requirements, the presentapplication constitutes a continuation-in-part of U.S. patentapplication Ser. No. 11/271,146, entitled REACTION DEVICE CONTROLLED BYRF CONTROL SIGNAL, naming Leroy E. Hood, Muriel Y. Ishikawa, Edward K.Y. Jung, Robert Langer, Clarence T. Tegreene, Lowell L. Wood, Jr. andVictoria Y. H. Wood as inventors, filed Nov. 9, 2005, which is currentlyco-pending, or is an application of which a currently co-pendingapplication is entitled to the benefit of the filing date.

7. For purposes of the USPTO extra-statutory requirements, the presentapplication constitutes a continuation-in-part of U.S. patentapplication Ser. No. 11/270,799, entitled REMOTE CONTROLLED IN SITUREACTION METHOD, naming Leroy E. Hood, Muriel Y. Ishikawa, Edward K. Y.Jung, Robert Langer, Clarence T. Tegreene, Lowell L. Wood, Jr. andVictoria Y. H. Wood as inventors, filed Nov. 9, 2005, which is currentlyco-pending, or is an application of which a currently co-pendingapplication is entitled to the benefit of the filing date.

8. For purposes of the USPTO extra-statutory requirements, the presentapplication constitutes a continuation-in-part of U.S. patentapplication Ser. No. 11/272,455, entitled REMOTE CONTROLLER FOR IN SITUREACTION DEVICE, naming Leroy E. Hood, Muriel Y. Ishikawa, Edward K. Y.Jung, Robert Langer, Clarence T. Tegreene, Lowell L. Wood, Jr. andVictoria Y. H. Wood as inventors, filed Nov. 9, 2005, which is currentlyco-pending, or is an application of which a currently co-pendingapplication is entitled to the benefit of the filing date.

9. For purposes of the USPTO extra-statutory requirements, the presentapplication constitutes a continuation-in-part of U.S. patentapplication Ser. No. 11/272,572, entitled REMOTE CONTROLLED IN VIVOREACTION METHOD, naming Leroy E. Hood, Muriel Y. Ishikawa, Edward K. Y.Jung, Robert Langer, Clarence T. Tegreene, Lowell L. Wood, Jr. andVictoria Y. H. Wood as inventors, filed Nov. 9, 2005, which is currentlyco-pending, or is an application of which a currently co-pendingapplication is entitled to the benefit of the filing date.

10. For purposes of the USPTO extra-statutory requirements, the presentapplication constitutes a continuation-in-part of U.S. patentapplication Ser. No. 11/272,573, IN SITU REACTION DEVICE, naming LeroyE. Hood, Muriel Y. Ishikawa, Edward K. Y. Jung, Robert Langer, ClarenceT. Tegreene, Lowell L. Wood, Jr. and Victoria Y. H. Wood as inventors,filed Nov. 9, 2005, which is currently co-pending, or is an applicationof which a currently co-pending application is entitled to the benefitof the filing date.

TECHNICAL FIELD

The present application relates, in general, to the field of osmoticpump devices and systems, and/or methods for remotely controlling theoperation of osmotic pump devices.

BACKGROUND

Implantable controlled release devices for drug delivery have beendeveloped. Certain devices rely upon the gradual release of a drug froma polymeric carrier over time, due to degradation of the carrier.Polymer-based drug release devices are being developed that include adrug in a ferropolymer that may be heated by an externally appliedmagnetic field, thus influencing the drug release. MEMS based drugrelease devices that include integrated electrical circuitry are alsounder development, as are MEMS based systems for performing chemicalreactions. Implantable osmotic pump devices have been developed for drugdelivery purposes. Wireless transmission of electromagnetic signals ofvarious frequencies is well known in the areas of communications anddata transmission, as well as in selected biomedical applications.

SUMMARY

The present application relates, in general, to the field of osmoticpump devices and systems. In particular, the present application relatesto remotely controlled osmotic pump devices that make use of controlsignals carried between a remote controller and an osmotic pump devicein an environment by electrical, magnetic, or electromagnetic fields orradiation. Embodiments of a system including a remotely controlledosmotic pump device and associated controller are described. Methods ofuse and control of the device are also disclosed. According to variousembodiments, an osmotic pump device is placed in an environment in orderto eject a material into the environment. Exemplary environments includea body of an organism, a body of water or other fluid, or an enclosedvolume of a fluid.

BRIEF DESCRIPTION OF THE FIGURES

FIG. 1 illustrates an embodiment of a system including a remotelycontrolled osmotic pump device;

FIGS. 2A and 2B illustrate operation of an osmotic pump device;

FIG. 3 depicts a remotely activatable element including a plurality ofelectromagnetically active elements;

FIG. 4 is a schematic diagram of an embodiment of an osmotic pumpdevice;

FIGS. 5A and 5B illustrate an embodiment of an osmotic pump device;

FIGS. 6A and 6B illustrate another embodiment of an osmotic pump device;

FIGS. 7A and 7B illustrate a further embodiment of an osmotic pumpdevice;

FIG. 8A depicts an exemplary interaction region;

FIG. 8B depicts expansion of the interaction region of FIG. 8A in afirst direction;

FIG. 8C depicts expansion of the interaction region of FIG. 8A in asecond direction;

FIG. 8D depicts expansion of the interaction region of FIG. 8A in firstand second directions;

FIGS. 9A and 9B depict an example of the effect of stretching of aninteraction region;

FIGS. 10A and 10B depict another example of an effect of stretching ofan interaction region;

FIGS. 11A and 11B depict unfolding of a pleated interaction region;

FIGS. 12A and 12B depict an exemplary embodiment of an interactionregion;

FIGS. 13A and 13B depict another exemplary embodiment of an interactionregion;

FIGS. 14A and 14B depict another exemplary embodiment of an interactionregion;

FIGS. 15A and 15B illustrate an increase in volume of an osmoticchamber;

FIG. 16 illustrates an osmotic pump device with a downstream fluidhandling structure;

FIG. 17 is a schematic diagram of an osmotic pump system including aremote controller;

FIG. 18 illustrates an embodiment of a system including a remotelycontrolled osmotic pump device;

FIG. 19 illustrates an embodiment of a system including a remotelycontrolled osmotic pump device;

FIG. 20 illustrates an embodiment of a system including a remotelycontrolled osmotic pump device;

FIG. 21 depicts an embodiment of a system including a remote controldevice, an osmotic pump device, and a sensor;

FIG. 22 depicts an embodiment of a system including a remote controldevice and an osmotic pump device including a sensor;

FIG. 23 depicts an embodiment of a system including a remote controldevice and an osmotic pump device;

FIG. 24 is a flow diagram of an embodiment of a method of controlling anosmotic pump device;

FIG. 25 is a flow diagram of an embodiment of a method of controlling anosmotic pump device;

FIG. 26 is a flow diagram of an embodiment of a method of controlling anosmotic pump device;

FIG. 27 is a flow diagram of an embodiment of a method of controlling anosmotic pump device;

FIG. 28 is a flow diagram of an embodiment of a method of controlling anosmotic pump device;

FIG. 29 illustrates a control signal generated from stored pattern data;

FIG. 30 illustrates a control signal calculated from a model based onstored parameters;

FIG. 31 depicts an exemplary control signal;

FIG. 32 depicts another exemplary control signal;

FIG. 33 depicts another exemplary control signal;

FIG. 34 illustrates an embodiment of a remote control device includingsoftware for controlling control signal generation and transmission;

FIG. 35 is a cross-sectional view of an osmotic pump device having avalve at an inlet;

FIG. 36 is a cross-sectional view of an osmotic pump device having avalve at an outlet;

FIG. 37 illustrates an embodiment of an osmotic pump device;

FIG. 38 is a cross-sectional view of an embodiment of a valve includinga remotely activatable valve element;

FIG. 39 is a cross-sectional view of an embodiment of a valve includinga remotely activatable valve element;

FIG. 40 depicts an embodiment of an osomptic pump device including adownstream fluid handling structure;

FIG. 41 is a schematic diagram of an osmotic pump system including aremote controller;

FIG. 42 depicts an embodiment of a system including a remote controldevice, an osmotic pump device, and a sensor;

FIG. 43 depicts an embodiment of a system including a remote controldevice and an osmotic pump device including a sensor;

FIG. 44 depicts an embodiment of a system including a remote controldevice and an osmotic pump device;

FIG. 45 is a flow diagram of an embodiment of a method of controlling anosmotic pump device;

FIG. 46 is a flow diagram of an embodiment of a method of controlling anosmotic pump device;

FIG. 47 is a flow diagram of an embodiment of a method of controlling anosmotic pump device;

FIG. 48 is a flow diagram of an embodiment of a method of controlling anosmotic pump device;

FIG. 49 depicts an embodiment of an osmotic pump device including twoosmotic pumps operating in parallel;

FIG. 50 depicts an embodiment of an osmotic pump device including twoosmotic pumps operating in series; and

FIG. 51 depicts an embodiment of an osmotic pump system includingmultiple osmotic pump devices.

DETAILED DESCRIPTION

FIG. 1 depicts a first exemplary embodiment of an osmotic pump system10. In the embodiment of FIG. 1, osmotic pump system 10 includes osmoticpump device 12 located in an environment 14, (which, in this particularexample, is a human body) and remote controller 16. As used herein, theterm “remote” refers to the transmission of information (e.g. data orcontrol signals) or power signals or other interactions betweenspatially separated devices or apparatuses, such as the remotecontroller or the osmotic pump system without a connecting element suchas a wire or cable linking the remote controller and the osmotic pumpsystem, and does not imply a particular spatial relationship between theremote controller and the osmotic pump device, which may, in variousembodiments, be separated by relatively large distances (e.g. miles orkilometers) or a relatively small distances (e.g. inches ormillimeters). Osmotic pump device 12 includes a remotely activatablecontrol element 18 that is responsive to an electromagnetic controlsignal generated by remote controller 16.

According to one exemplary embodiment of an osmotic pump device, asdepicted in FIGS. 2A and 2B, an osmotic pump system may include a bodystructure 52 configured for placement in an environment 54, a deliveryreservoir 56 capable of containing a delivery fluid 58 to be deliveredinto the environment 54, e.g. via outlet 60, an osmotic chamber 62, apressure-responsive movable barrier 64 separating the osmotic chamber 62from delivery reservoir 56, and semi-permeable membrane 66 separatingthe osmotic chamber 62 from an osmotic fluid source, which in thisexample is environment 54. An osmotic pressure-generating material 70may be contained within the osmotic chamber 62, with the generation ofosmotic pressure by the osmotic pressure-generating material 70controllable by an electromagnetic field control signal. Thepressure-responsive movable barrier 64 may be substantially impermeableto the osmotic pressure-generating material 70 and configured to move inresponse to a change in pressure in the osmotic chamber 62 to produce achange in at least one of pressure or volume in the delivery reservoir56, and the semi-permeable membrane 66 separating the osmotic chamber 62from an osmotic fluid source 68 may be substantially permeable by fluid71 from the osmotic fluid source 68 but substantially impermeable to theosmotic pressure-generating material 70. The pressure-responsive movablebarrier 64 may include a flexible membrane 64, as depicted in FIGS. 2Aand 2B, or a piston, as depicted in, e.g., FIGS. 5A and 5B at referencenumber 206.

The body structure of the osmotic pump device (e.g. body structure 52 inFIG. 2A) may be adapted for a specific environment. The size, shape, andmaterials of the body structure influence suitability for a particularenvironment. For example, a device intended for use in a body of a humanor other organism would typically have suitable biocompatibilitycharacteristics. For use in any environment, the body structure (anddevice as a whole) may be designed to withstand environmental conditionssuch as temperature, chemical exposure, and mechanical stresses.Moreover, the body structure may include features that allow it to beplaced or positioned in a desired location in the environment, ortargeted to a desired location in the environment. Such features mayinclude size and shape features, tethers or gripping structures toprevent movement of the body structure in the environment (in the casethat the device is placed in the desired location) or targeting features(surface chemistry, shape, etc.) that may direct the device toward orcause it to be localized in a desired location. Small devices (e.g. asmay be used for placement in the body of an organism) may be constructedusing methods known to those in skill of the art of microfabrication. Inapplications where size is not a constraint, a wide variety offabrication methods may be employed. The body structure of the osmoticpump device may be formed from various materials or combinations ofmaterials, including but not limited to plastics and other polymers,ceramics, metals, and glasses, and by a variety of manufacturingtechniques. In some embodiments, the osmotic fluid source may be theenvironment, while in other embodiments, the osmotic pump system mayinclude a fluid-containing reservoir that serves as an osmotic fluidsource.

Various different osmotic pressure-generating materials may be used inosmotic pump systems as described herein. For example, the osmoticpressure-generating material may include ionic and non-ionicwater-attracting or water absorbing materials, non-volatilewater-soluble species, salts, sugars, polysaccharides, polymers,hydrogels, osmoopolymers, hydrophilic polymers, and absorbent polymers,among others. Water-attracting materials may include non-volatile,water-soluble species such as magnesium sulfate, magnesium chloride,potassium sulfate, sodium chloride, sodium sulfate, lithium sulfate,sodium phosphate, potassium phosphate, d-mannitol, sorbitol, inositol,urea, magnesium succinate, tartaric acid, raffinose, variousmonosaccharides, oligosaccharides and polysaccharides, such as sucrose,glucose, lactose, fructose, dextran, and mixtures thereof. Waterabosorbing materials include osmoopolymers, for example hydrophilicpolymers that swell upon contact with water. Examples of water-absorbingmaterials include poly(hydroxyl alkyl methacrylates) MW30,000-5,000,000, polyvinylpyrrolidone MW 10,000-360,000, anionic andcationic hydrogels, polyelectrolyte complexes, poly(vinyl alcohol)having low acetate residual, optionally cross linked with glyoxal,formaldehyde, or glutaraldehyde and having a degree of polymerization of200 to 30,000, mixtures of e.g., methylcellulose, cross linked agar andcarboxymethylcellulose; or hydroxypropyl methycellulose and sodiumcarboxymethylcellulose; polymers of N-vinyllactams, polyoxyethylenepolyoxypropylene gels, polyoxybutylene-polyoxethylene block copolymergels, carob gum, polyacrylic gels, polyester gels, polyuria gels,polyether gels, polyamide gels, polypeptide gels, polyamino acid gels,polycellulosic gels, carbopol acidic carboxy polymers MW250,000-4,000,000, cyanamer polyacrylamides, cross-linked indene-maleicanhydride polymers, starch graft copolymers, acrylate polymerpolysaccharides. Other water attracting and/or water absorbing materialsinclude absorbent polymers such as poly(acrylic acid) potassium salt,poly(acrylic acid) sodium salt, poly(acrylic acid-co-acrylamide)potassium salt, poly(acrylic acid) sodium salt-graft-poly(ethyleneoxid), poly(2-hydroxethyl methacrylate) and/or poly(2-hydropropylmethacrylate) and poly(isobutylene-co-maleic acid). A variety of osmoticpressure-generating materials and/or water-absorbing materials aredescribed in US 2004/0106914 and US 2004/0015154, both of which areincorporated herein by reference in its entirety.

The osmotic pressure-generating ability of the osmoticpressure-generating material may depend on the solubility of the osmoticpressure-generating material in the osmotic fluid, and/or upon theconcentration of the osmotic pressure-generating material in the osmoticfluid, and varying either concentration or solubility may modify theosmotic-pressure generating abiligy of the osmotic pressure-generatingmaterial. Concentration of the osmotic pressure-generating material inthe osmotic fluid may be modifiable by a change in solubility of theosmotic pressure-generating material in response to an electromagneticfield control signal or by a change in the osmotic fluid in response toan electromagnetic field control signal.

The osmotic pump system of FIGS. 2A and 2B may include a remotelyactivatable control element 72 responsive to the electromagnetic fieldcontrol signal to control the generation of osmotic pressure by theosmotic pressure-generating material 70. As depicted in FIG. 2A, aportion 74 of osmotic pressure-generating material 70 is not insolution. Following activation of remotely activatable control element72, a larger amount of the osmotic pressure-generating material 70 is insolution, as depicted in FIG. 2B, to produce a higher concentration ofosmotic pressure-generating material 70, and thus a larger flow ofosmotic fluid 71 into osmotic chamber 62, and an increased pumping rateof delivery fluid 58 out of delivery reservoir 56.

Remotely activatable control elements used in various embodiments ofosmotic pump devices and systems may include one or moreelectromagnetically active material, for example a magnetically activematerial such as a permanently magnetizable material, a ferromagneticmaterial, a ferrimagnetic material, a ferrous material, a ferricmaterial, a dielectric material, a ferroelectric material, apiezoelectric material, a diamagnetic material, a paramagnetic material,an antiferromagnetic material, or an electrically active material, suchas a permanently ‘poled’ dielectric, a ferroelectric, a dielectric or apiezoelectric material.

Remotely activatable control elements may, in some embodiments, bycomposite structures. FIG. 3 depicts an example of a remotelyactivatable control element 100 including a composite structure formedfrom a polymer 102 and multiple electrically or magnetically activecomponents in the form of multiple particles 104 distributed throughpolymer 102. In some embodiments, the electrically or magneticallyactive components may be heatable by the electromagnetic control signal,and heating of the electrically or magnetically active components maycause the polymer to undergo a change in configuration. An example of amagnetically responsive polymer is described, for example, in Neto, etal, “Optical, Magnetic and Dielectric Properties of Non-LiquidCrystalline Elastomers Doped with Magnetic Colloids”; Brazilian Journalof Physics; bearing a date of March 2005; pp. 184-189; Volume 35, Number1, which is incorporated herein by reference. Other exemplary materialsand structures are described in Agarwal et al., “Magnetically-driventemperature-controlled microfluidic actuators”; pp. 1-5; located at:http://www.unl.im.dendai.ac.jp/INSS2004/INSS2004_papers/OralPresentations/C2.pdfor U.S. Pat. No. 6,607,553, both of which are incorporated herein byreference.

In some embodiments, the remotely activatable control element mayinclude a shape memory material, such as a shape memory polymer or ashape memory metal. In other embodiments, the remotely activatablecontrol element may include a bimetallic structure. In still otherembodiments, the remotely activatable control element may include apolymer, ceramic, dielectric or metal. In some embodiments, the remotelyactivatable control element may include at least one of a hydrogel, aferrogel or a ferroelectric. The remotely activatable control elementmay include a composite material or structure, such as a polymer and amagnetically or electrically active component.

The response of the remotely activatable control element to anelectromagnetic field may be due to absorption of energy from theelectromagnetic signal or due to torque or traction on all or a portionof the remotely activatable control element due to the electromagneticfield. The response will depend upon the intensity, the relativeorientation and the frequency of the electromagnetic field and upon thegeometry, composition and preparation of the material of the remotelyactivatable control element. A response may occur on the macro level, ona microscopic level, or at a nanoscopic or molecular level.

The remotely activatable control element may have various functionalcharacteristics. In some embodiments, the remotely activatable controlelement may include or form a heating element (e.g., a resistiveelement) or a cooling element (which may be, for example, athermoelectric device). In some embodiments, the remotely activatablecontrol element may be an expanding element. In some embodiments, aremotely activatable control element may include a receiving elementsuch as an antenna or other geometric gain structure to enhance thereceiving of an electromagnetic control signal transmitted from a remotecontrol signal generator.

FIG. 4 depicts in schematic form an embodiment of an osmotic pump device150 including a remotely activatable control element 152 that includesan active portion 154 and a receiving element 156. Osmotic pump device150 also includes osmotic chamber 158 and delivery reservoir 160. Thereceiving element 156 may be any structure that has a size, shape, andmaterial that is suitable for receiving and transducing electromagneticenergy of a particular frequency or frequency band. In some embodiments,receiving element 156 may be highly frequency-selective, while in otherembodiments it may react usefully over a wide frequency band, or overmultiple frequency bands. Receiving element 156 may be formed of variousmetallic or electrically or magnetically active materials. Activeportion 154 may include various materials that respond mechanically,thermally or chemically to electromagnetic energy received andtransduced by receiving element 156 to influence the generation ofosmotic pressure in osmotic chamber 158 or the flow of fluid intoosmotic chamber 158 or out of delivery reservoir 160, and consequentlyto modify the pumping rate of fluid from delivery reservoir 160.

One method by which a remotely activatable control element may respondto the control signal is by producing or by absorbing heat. In someembodiments, a change in temperature of the remotely activatable controlelement may modify the generation of osmotic pressure directly. As shownin FIGS. 5A and 5B, in one embodiment the osmotic pump system mayinclude an osmotic pump device 200 including a remotely activatablecontrol element 202 that is an electromagnetic field activated heatingelement capable of producing an increase in temperature in the osmoticfluid, wherein the osmotic pressure-generating material 70 has asolubility in the osmotic fluid 71 that changes in response to anincrease in temperature of the osmotic fluid. Osmotic pump device 200may include an osmotic chamber 62 and delivery reservoir 56 containingdelivery fluid 58, which may be ejected through outlet 60. The osmoticpump system 200 includes semi-permeable barrier 66 and osmotic fluidsource (e.g. environment 54) as described previously in connection withFIGS. 2A and 2B. Pressure-responsive movable barrier 206 is depicted asa piston or slidable wall, rather than as the flexible membrane shown inFIGS. 2A and 2B, but is substantially functionally equivalent. Osmoticpressure generating material 70 is contained within osmotic chamber 62.Remotely activatable control element 202 may be located in the wall ofosmotic chamber 62. Remotely activatable control element 202 has aninitial temperature T₁. Following heating of remotely activatablecontrol element 202 in response to an electromagnetic control signal,remotely activatable control element 202 has a subsequent temperatureT₂, as shown in FIG. 5B. The change in temperature of remotelyactivatable control element 202 may modify the concentration of osmoticpressure generating material 70 within osmotic chamber 62. In FIG. 5A,portion 204 of osmotic pressure-generating material 70 is insoluble,while in FIG. 5B, all of osmotic pressure-generating material 70 hasgone into solution, due to the change in temperature of osmotic fluid71. The electromagnetic field activated heating element 202 may includea ferrous, ferric, or ferromagnetic material, or other material with asignificant electromagnetic “loss tangent” or resistivity. In thepresent example, the solubility of the osmotic pressure-generatingmaterial 70 in the osmotic fluid 71 is depicted as increasing withincreasing temperature, but in some embodiments, the solubility maydecrease with increasing temperature.

In some embodiments, the osmotic pump system may include anelectromagnetic field activated cooling element capable of producing adecrease in temperature in the osmotic fluid, wherein the osmoticpressure-generating material has a solubility in the osmotic fluid thatchanges in response to an decrease in temperature of the osmotic fluid.For example, the electromagnetic field activated cooling element mayinclude a thermoelectric element. The solubility of the osmoticpressure-generating material may increase with decreasing temperature,or it may decrease with decreasing temperature. The concentration of theosmotic pressure-generating material in the osmotic fluid may bemodifiable by a change in the volume of the osmotic chamber in responseto the electromagnetic field control signal.

FIGS. 6A and 6B depict an osmotic pump device 250 in which remotelyactivatable control element 252 responds to an electromagnetic controlsignal by producing cooling. Methods and/or mechanisms of producingcooling may include, but are not limited to, thermoelectric (PeltierEffect) and liquid-gas-vaporization (Joule-Thomson) devices, or deviceswhich employ “phase-changing” materials involving significant enthalpiesof transition. In FIG. 6A, for example, cooling element 252 may beactivated to produce cooling to temperature T₁, and hence a lowerosmotic pressure in osmotic chamber 62. In FIG. 6B, the electromagneticcontrol signal may be modified so that cooling element 252 no longerproduces cooling, and the temperature increases to a higher temperatureT₂. The pressure in osmotic chamber 62 then increases to produce anincrease in the flow of osmotic fluid 71 into osmotic chamber 62, with acorresponding increase in pumping rate of delivery fluid 58 fromdelivery reservoir 56 into the environment 54, via outlet 60.

In some embodiments, a change in temperature of a remotely activatablecontrol element of an osmotic pump device element may modify thegeneration of osmotic pressure, and hence the pumping rate, indirectly,for example by producing a change in dimension of a structure (which maybe, for example, similar to the remotely activatable control elementdepicted in FIG. 3). FIG. 7A depicts osmotic pump system 300, includingdelivery reservoir 56 containing delivery fluid 58 and osmotic chamber62 containing osmotic pressure generating material 70, pressureresponsive movable barrier 64 and semi-permeable membrane 66, asdescribed previously. Osmotic pump system 300 may include remotelyactivatable control element 302, which may change in dimension inresponse to an electromagnetic control signal. The change in dimensionmay be due to heating, or removal or loss of heat. Remotely activatablecontrol element 302 may be located in the wall of osmotic chamber 62, asdepicted in FIGS. 7A and 7B. An interaction region 304 includinginteraction sites 306 may be located on or adjacent to remotelyactivatable control element 302, so that the dimension of interactionregion 304 is modified with the change in dimension of remotelyactivatable control element 302. Interaction sites 306 may bind osmoticpressure generating material 70, thus keeping it out of solution, andmaintaining a lower osmotic pressure in osmotic chamber 62; a change inspacing or exposure of interaction sites 306 may modify the interactionof osmotic pressure generating material 70 with interaction sites 306,and thus modifies the osmotic pressure in osmotic chamber 62. Forexample, in FIG. 7B, the remotely activatable control element hascontracted in at least one dimension to produce a corresponding decreasein size of interaction region 304, and reduction in spacing betweeninteraction sites 306. In the example depicted in FIG. 7B, the reductionin interaction site spacing reduces interactions with osmotic pressuregenerating material 70, causing it to go into solution in fluid 71 inhigher concentration.

The interaction sites may be localized to an interaction region, asdepicted in FIGS. 7A and 7B, or the interaction sites may be distributedto various locations within the osmotic chamber. The osmotic pump mayinclude a plurality of interaction sites for the osmoticpressure-generating material within the osmotic chamber, the likelihoodof interaction of the osmotic pressure-generating material with theinteraction sites controllable by the electromagnetic field controlsignal, wherein interaction of the osmotic pressure-generating materialwith the interaction sites causes a change in osmotic pressure withinthe osmotic chamber. The interaction sites may be capable of interactingwith the osmotic pressure generating material by one or more of binding,reacting, interacting, or forming a complex with the osmoticpressure-generating material. The interaction sites may be responsive toan electromagnetic field control signal by a change in at least onecharacteristic, the change in the at least one characteristic modifyingthe interaction between the interaction sites and the osmoticpressure-generating material. The at least one characteristic mayinclude, but is not limited to, at least one of a solubility, areactivity, a distribution within the osmotic chamber, a density, atemperature, a conformation, an orientation, an alignment, or chemicalpotential, for example.

At least a portion of the osmotic chamber containing the interactionsites (e.g. interaction region 304 in FIGS. 7A and 7B) may be responsiveto an electromagnetic field control signal by a change in the surfacearea of the portion of the osmotic chamber, the change in surface areamodifying at least one of the number of interaction sites or likelihoodof interaction of the osmotic pressure-generating material with theinteraction sites. The change of surface area may be produced bystretching of the portion of the osmotic chamber, as depicted in FIGS.8A-8D, or the change of surface area may be produced by unfolding of theportion of the osmotic chamber, as depicted in FIGS. 11A and 11B, or bysome of change in conformation of at least a portion of the osmoticchamber.

FIGS. 8A-8D depict the effect of changes in one or two dimensions on aninteraction region 340. For example, the interaction region may beformed on a remotely activatable control element that expands inresponse to a control signal. Interaction region 340 may include aplurality of reaction sites 342, and having initial length of x₁ in afirst dimension and y₁ in a second dimension. FIG. 8B depictsinteraction region 340 following a change in the first dimension, to alength x₂. FIG. 8C depicts interaction region 340 following a change inthe second dimension, to a length y₂, and FIG. 8D depicts interactionregion 340 following a change in both the first and second dimensions,to a size of x₂ by y₂. In each case, a change in dimension results in achange in distance between reaction sites 342. The dimension changedepicted in FIGS. 8A-8D may be viewed as a ‘stretching’ or ‘expansion’of the interaction region. Increasing the surface area of theinteraction region may increase the rate of the reaction. Increasing thesurface area of the interaction region (e.g., by stretching the surface)may increase the distance between reaction sites on the interactionregion. An increased distance between reaction sites may lead to anincrease in reaction rate (for example, in cases where smaller spacingbetween reaction sites leads to steric hindrance that blocks access ofreactants to reaction sites).

The influence of modifying the surface area of an interaction region isdescribed further in connection with FIGS. 9A and 9B and 10A and 10B.FIGS. 9A and 9B illustrate how an increase of the surface area of aninteraction region by stretching or expansion may increase the rate ofthe interaction occurring at the interaction region. Multipleinteraction sites 352 are located in interaction region 350. As shown inFIG. 9A, prior to stretch or expansion, interaction sites 352 are closetogether, and reactant 354, which binds to the interaction sites 352, issufficiently large that it is not possible for reactant 354 to bind toeach interaction site 352. When interaction region 350 has beenstretched or expanded to expanded form 350′ as depicted in FIG. 9B, sothat the interaction sites 352 are further apart, it is possible forreactant 354 to bind to a larger percentage of the interaction sites,thus increasing the rate of interaction.

In some embodiments, an increase in the surface area of the interactionregion by stretching or expansion may decrease the interaction rate (forexample, in cases where a particular spacing is needed to permit bindingor association of reactants with several interaction sitessimultaneously). FIGS. 10A and 10B illustrate how an increase in thesurface area of an interaction region 400 by stretching or expansion maydecrease the rate of the interaction occurring at the interactionregion. Again, multiple interaction sites 402 and 404 are located in theinteraction region 400, as depicted in FIG. 10A. In the present examplebinding of a reactant 406 to interaction region 400 requires binding ofa reactant 406 to two interaction sites 402 and 404. When interactionregion 400 is stretched or expanded to expanded form 400′ as depicted inFIG. 10B, the spacing of the two interaction sites 402 and 404 ischanged so that reactant 406 does not readily bind to interaction regionin the expanded form 400′, thus reducing the rate of interaction.

Many materials expand when thermal energy is applied. By combiningmaterials as in polymer gels one can use the differing properties ofindividual components to affect the whole. Thermally-responsivematerials include thermally responsive gels (hydrogels) such asthermosensitive N-alkyl acrylamide polymers, Poly(N-isopropylacrylamide)(PNIPAAm), biopolymers, crosslinked elastin-based networks, materialsthat undergo thermally triggered hydrogelation, memory foam, resincomposites, thermochromic materials, proteins, memory shape alloys,plastics, and thermoplastics. Materials that contract or fold inresponse to heating may include thermally-responsive gels (hydrogels)that undergo thermally triggered hydrogelation (e.g. Polaxamers,uncross-linked PNIPAAm derivatives, chitosan/glycerol formulations,elastin-based polymers), thermosetting resins (e.g. phenolic, melamine,urea and polyester resins), dental composites (e.g.monomethylacrylates), and thermoplastics.

Some examples of reactions that may be sped up by change in distancebetween reaction sites include those involving drugs designed withspacers, such as dual function molecules, biomolecules linked totransition metal complexes as described in Paschke et al, “Biomoleculeslinked to transition metal complexes-new chances for chemotherapy”;Current Medicinal Chemistry; bearing dates of October 2003 and Oct. 18,2005, printed on Oct. 24, 2005; pp. 2033-44 (pp. 1-2); Volume 10, Number19; PubMed; located at:http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12871101&dopt=Abstract,and Schiff bases as described in Puccetti et al., “Carbonic anhydraseinhibitors”, Bioorg. Med. Chem. Lett. 2005 June 15; 15(12): 3096-101(Abstract only), both of which are incorporated herein by reference.Other reactions include reactions responding to conformational(allosteric) changes including regulation by allosteric modulators, andreactions involving substrate or ligand cooperativity in multiple-siteproteins, where binding affects the affinity of subsequent binding,e.g., binding of a first O₂ molecule to Heme increases the bindingaffinity of the next such molecule, or influence of Tau on Taxol, asdescribed in Ross et al., “Tau induces cooperative Taxol binding tomicrotubules”; PNAS; Bearing dates of Aug. 31, 2004 and 2004; pp.12910-12915; Volume 101, Number 35; The National Academy of Sciences ofthe USA; located at:http://gabriel.physics.ucsb.edu/˜deborah/pub/RossPNASv101p12910y04.pdf,which is incorporated herein by reference. Reactions that may be sloweddown by increased reaction site spacing include reactions responsive toconformational (allosteric) changes, influence or pH, or crosslinking.See for example Boniface et al., “Evidence for a Conformational Changein a Class II Major Histocompatibility Complex Molecule Occurring in theSame pH Range Where Antigen Binding Is Enhanced”; J. Exp. Med.; Bearingdates of January 1996 and Jun. 26, 2005; pp. 119-126; Volume 183; TheRockefeller University Press; located at: http://www.jem.org alsoincorporated herein by reference or Sridhar et al., “New bivalent PKCligands linked by a carbon spacer: enhancement in binding affinity”; JMed. Chem.; Bearing dates of Sep. 11, 2003 and Oct. 18, 2005, printed onOct. 24, 2005; pp. 4196-204 (pp. 1-2); Volume 46, Number 19; PubMed(Abstract); Located at:http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=PubMed&list_uids=12954072&dopt=Abstract,also incorporated herein by reference.

In addition to increasing surface areas or reaction volumes, expansionof a remotely activatable control element may also have the effect ofexposing additional portions of an interaction region or exposingadditional functional group to influence a reaction condition.Increasing the surface area of the interaction region by unfolding orother forms of ‘opening’ of the interaction region structure of at leasta portion of the reaction area may increase the number of reaction siteson the interaction region (e.g. by exposing additional reaction sitesthat were fully or partially hidden or obstructed when the interactionregion was in a folded configuration). For example, the area of aninteraction region may be increased by the unfolding of at least aportion of the reaction area to expose additional portions of thereaction area, as depicted in FIGS. 11A and 11B. In FIG. 11A, aninteraction region 450, which includes or is made up of a remotelyactivatable control element, can be expanded by unfolding to the formdepicted in FIG. 11B. Interaction region 450 has a pleated structurethat includes ridges 452 a-452 e and valleys 454 a-454 d. Reaction sites456 may be located in or on ridges 452 a-452 e and valleys 454 a-454 d.In the folded form illustrated in FIG. 11A, reaction sites 456 locatedin valleys 454 a-454 d are ‘hidden’ in the sense that reactants may notfit into the narrow valleys to approach those reaction sites, whilereaction sites on ridges 452 a-452 e remain exposed. When interactionregion 450 is unfolded to the form shown in FIG. 11B, reaction sites 456in valleys 454 a-456 d are exposed, because the open valleys permitaccess of reactants to the reaction sites in the valleys. Examples ofmaterials that unfold in response to electromagnetic fields includeionic polymer-metal composites (IPMC) as described in Shahinpoor et al.,“Artificial Muscle Research Institute: Paper: Ionic Polymer-MetalComposites (IPMC) As Biomimetic Sensors, Actuators and ArtificialMuscles-A Review”; University of New Mexico; printed on Oct. 21, 2005;pp. 1-28; located at: http://www.unm.edu/˜amri/paper.html, which isincorporated herein by reference.

Increasing the surface area of the interaction region may decrease therate of the interaction in some circumstance and increase the rate ofinteraction in others. Exposure of additional portions of theinteraction region may expose additional functional groups that are notreaction sites, but that may produce some local modification to asurface property of the interaction region that in turn modifies therate or kinetics of the reaction. For example, exposed functional groupsmay produce at least a local change in pH, surface energy, or surfacecharge. See, for example, U.S. patent publication 2003/0142901 A1, whichis incorporated herein by reference.

A related modification of the interaction region may include an increasein porosity or decrease in density of a remotely activatable controlelement. An increase in porosity may have a similar effect to theunfolding depicted in FIGS. 11A and 11B with respect to modifying thespacing or exposure of reaction sites, functional groups, etc. See, forexample U.S. Pat. Nos. 5,643,246, 5,830,207, and 6,755,621, all of whichare incorporated herein by reference.

A change in the spacing of interaction sites may increase or decreasethe rate of interaction, or modify another parameter of an interaction,in a manner that depends on the specific reaction and reactants. Heatingor cooling of a reaction volume may also modify a chemical reaction bymodifying the pressure or the pH or the osmolality or otherreaction-pertinent chemical variables within the reaction space.

In some embodiments, the osmotic pump device may include a secondarymaterial within the osmotic chamber, the secondary material having atleast one characteristic modifiable by the electromagnetic field controlsignal, wherein the concentration of the osmotic pressure-generatingmaterial is modifiable by a change in the at least one characteristic ofthe secondary material. The secondary material may include, for example,a material capable of binding, reacting, interacting, or forming acomplex with the osmotic pressure-generating material. The at least onecharacteristic may include at least one of a solubility, a reactivity, adistribution within the osmotic chamber, a density, a temperature, aconformation, an orientation, an alignment, or a chemicalpotential-modifying mechanism.

In various embodiments as described herein, the interaction region mayinclude interaction sites, which may include a secondary materialcapable of interacting with or influencing the behavior of the osmoticpressure-generating material. The remotely activatable control elementmay modify the influence of the secondary material. In some embodimentsthe secondary material may not be localized to an interaction region,but may be distributed within the osmotic chamber, but responsive to anelectromagnetic control signal.

The secondary material may interact with or influence osmotic pressuregenerating material in a variety of ways. As a first example, thesecondary material may be a receptor or other binding location thatbinds or sequesters the osmotic pressure generating material, eitherspecifically or non-specifically, to take it out of solution. FIGS. 12Aand 12B depict an interaction between osmotic pressure generatingmaterial 500 and secondary material 502 in interaction region 504. InFIG. 12A, prior to activation of remotely activatable control element506, osmotic pressure generating material 500 does not bind to secondarymaterial 502 in interaction region 504. Following activation of remotelyactivatable control element 506, secondary material 502 undergoes achange to modified form 502′ as depicted in FIG. 12B, which allowsosmotic pressure generating material 500 to bind to it and go out ofsolution, thus reducing the osmotic pressure.

In the example shown in FIGS. 13A and 13B, secondary material 550 is notitself a receptor or binding site for the osmotic pressure generatingmaterial 552, but modifies interaction between the osmotic pressuregenerating material 552 and an interaction site 554 (which may be, forexample, a binding or receptor site) in interaction region 556. In FIG.13A, the secondary material 550 is in a first configuration which blocksaccess of osmotic pressure generating material 552 to interaction site554. In FIG. 13B, under the influence of remotely activatable controlelement 558, secondary material 550 has assumed a second configuration550′ which permits access of osmotic pressure generating material 552 tointeraction site 554. Secondary material 550 may be a material thatmodifies the rate or nature of the interaction between osmotic pressuregenerating material 552 and interaction site 554 in response to anelectromagnetic control signal by steric effects, by modifying thepolarity of at least a portion of an interaction region, such as e.g.,hydrophobic or hydrophilic groups; by modifying the pH of at least aportion of the interaction region, with acids or acidifiers (e.g.,ammonium chloride), bases or alkalizers (sodium bicarbonate, sodiumacetate) or buffering agents (e.g., mono- or di-hydrogen phosphates); orit may be a material that modifies the charge of at least a portion ofthe interaction region, such as including various enzyme, neuraminidase,transferase, antioxidants, and charge donors.

In the example of FIGS. 14A and 14B, secondary material 600 is areactant that reacts with osmotic pressure generating material 602 toproduce reaction product 604. Osmotic pressure generating material 602approaches secondary material 600 in interaction region 606 in FIG. 14A,and reaction product 604 leaves interaction region 606 in FIG. 14B. Thereaction between secondary material 600 and osmotic pressure generatingmaterial 602 is caused, produced, facilitated, or otherwise increased orenhanced by activation of remotely activatable control element 608,(e.g., to produce heating, a cooling, a change in surface charge,conformation, etc.) Reaction product 606 may have a different osmoticpressure generating ability than osmotic pressure generating material602 due to different solubility, or because the reaction results in anincrease or decrease in the number of osmotic pressure generatingmolecules in the reaction chamber. A reaction by-product 610 may remainat interaction region 606, as depicted in FIG. 13B, or secondarymaterial 600 may be completely consumed by the reaction.

The influence of the remotely activatable control element in theexamples depicted in FIGS. 12A-14B may be any of various influences,including but not limited to those described herein; e.g., modifying thetemperature of the interaction region or exposing reaction sites orfunctional groups. The interaction that takes place at the interactionregion may change the osmotic pressure within the reaction chamber bychanging the concentration of osmotic pressure-generating materialwithin the osmotic chamber by producing reaction products in differentquantities or with different solubility or chemical activity than thereactants. In some embodiments, the interaction region may include acatalyst that facilitates a chemical reaction but is not modified by thechemical reaction, for example, metals such as platinum, acid-basecatalysts, catalytic nucleic acids such as ribozymes or DNAzymes. Theinteraction region may include an enzyme, such as an oxidoreductase(e.g. glucose oxidase), transferase (including glycosyltransferase,kinase/phosphorylase), hydrolase, lyase, isomerase, ligase, andenzymatic complexes and/or cofactors. Various examples of catalysts areprovided in Kozhevnikov, “Catalysts for Fine Chemical Synthesis, Volume2, Catalysis by Polyoxometalates”; Chipsbooks.com; Bearing dates of 2002and 1998-2006, printed on Oct. 21, 2005; pp 1-3 (201 pages); Volume 2;Culinary and Hospitality Industry Publications Services; located at:http://www.chipsbooks.com/catcem2.htm, which is incorporated herein byreference.

Modifying a reaction condition at the interaction region may also beaccomplished by heating or cooling at least a portion of the interactionregion, or by modifying the osmolality or pH, surface charge, or surfaceenergy of at least a portion of the interaction region. Similarly,modifying a reaction condition at the interaction region may includemodifying a parameter of a reaction space within the osmotic pumpdevice, the reaction space containing the interaction region, e.g. bymodifying the volume of the reaction space, heating or cooling at leasta portion of the reaction space, or modifying the osmolality, pH,pressure, temperature, chemical composition, or chemical activity of atleast a portion of the reaction space.

In some embodiments, expansion or other comformation change of aremotely activatable control element may produce other modifications toa chemical reaction. For example, a volume of a reaction spacecontaining the interaction region may be increased by expansion of aremotely activatable control element, as depicted in FIGS. 15A and 15B.An osmotic pump device 650 includes osmotic chamber 652 containingosmotic pressure generating material 70 and having a first volume asshown in FIG. 15A. Osmotic pump device 650 also include deliveryreservoir 654 containing a delivery fluid 656. A remotely activatablecontrol element 658 that changes dimension in response to anelectromagnetic control signal forms an expandable portion of the wallof osmotic chamber 652. Upon expansion of remotely activatable controlelement to expanded form 658′ shown in FIG. 15B, the volume of reactionspace osmotic chamber 652 is increased. The concentration of osmoticpressure-generating material 70 within osmotic chamber 652 is thusdecreased, which may have a corresponding influence on the osmoticpumping rate.

The effects illustrated in FIGS. 8A-8D, 11A-11B, and 15A-15B may bereversed by suitable adjustment to the control signal, leading tocorresponding decrease in interaction region surface area, volume of thereaction space, or number of exposed reaction sites.

As depicted in various embodiments, e.g., as shown in FIGS. 2A and 2B,5A and 5B, 6A and 6B, 7A and 7B, and 15A and 15B, the delivery reservoirmay include an outlet through which the delivery fluid moves into theenvironment in response to the change in at least one of pressure orvolume in the delivery reservoir. Alternatively, as depicted in FIG. 16,an osmotic pump system 700 may include a downstream fluid handlingstructure 702 in fluid communication with the delivery reservoir 56 andconfigured to receive fluid 58 ejected from the delivery reservoir 56 inresponse to the change in at least one of pressure or volume in thedelivery reservoir 56. The downstream fluid handling structure 702 mayinclude a chamber, as depicted in FIG. 16, a channel, or a combinationof one or more channels, chambers, or other fluid handling structures.Examples of fluid handling structures suitable for use in selectedembodiments are described in U.S. Pat. Nos. 6,146,103 and 6,802,489, andin Krau et al., “Fluid pumped by magnetic stress”; Bearing a date ofJul. 1, 2004; pp. 1-3; located at:http://arxiv.org/PS_cache/physics/pdf/0405/0405025.pdf, all of which areincorporated herein by reference. Fluid handling structures may include,but are not limited to, channels, chambers, valves, mixers, splitters,accumulators, pulse-flow generators, and surge-suppressors, amongothers.

FIG. 17 is a schematic diagram of an embodiment of an osmotic pumpsystem 750, which may include an osmotic pump device 752 and a remotecontrol signal source 754 capable of generating an electromagnetic fieldcontrol signal 756 sufficient to control the generation of osmoticpressure by the osmotic pressure-generating material 70 within theosmotic chamber 62 of the osmotic pump device 752. The osmotic pumpdevice 752 may include a body structure 52 configured for placement inan environment 54; a delivery reservoir 56 capable of containing adelivery fluid 58 to be delivered into the environment 54; osmoticchamber 62; osmotic pressure-generating material 70 contained within theosmotic chamber, the generation of osmotic pressure by the osmoticpressure-generating material 70 controllable by an electromagnetic fieldcontrol signal 756; a pressure-responsive movable barrier 758 separatingthe osmotic chamber 62 from the delivery reservoir 56, thepressure-responsive barrier 758 being substantially impermeable to theosmotic pressure-generating material 70 and configured to move inresponse to a change in pressure in the osmotic chamber 62 to produce achange in at least one of pressure or volume in the delivery reservoir56; and a semi-permeable membrane 66 separating the osmotic chamber 62from an osmotic fluid source, the semi-permeable membrane 66 beingsubstantially permeable to fluid from the osmotic fluid source butsubstantially impermeable to the osmotic pressure-generating material.

The remote control signal source 754 may include electrical circuitry760, signal generator 762, and signal transmitter 764, and may beconfigured to produce an electromagnetic control signal 756 havingvarious characteristics, depending upon the intended application of thesystem. Design specifics of electrical circuitry 760, signal generator762, and signal transmitter 764 will depend upon the type ofelectromagnetic control signal 756. The design of circuitry and relatedstructures for generation and transmission of electromagnetic signalscan be implemented using tools and techniques known to those of skill inthe electronic arts. See, for example, Electrodynamics of ContinuousMedia, 2^(nd) Edition, by L. D. Landau, E. M. Lifshitz and L. P.Pitaevskii, Elsevier Butterworth-Heinemann, Oxford, especially but notexclusively pp. 1-13- and 199-222, which is incorporated herein byreference, for discussion of theory underlying the generation andpropagation of electrical, magnetic, and electromagnetic signals. Theelectronic circuitry may include any or all of analog circuitry, digitalcircuitry, one or more microprocessors, computing devices, memorydevices, and so forth. Remote control signal source 754 may include atleast one of hardware, firmware, or software configured to controlgeneration of the electromagnetic control field signal.

The osmotic pump device 752 of the osmotic pump system may include abody structure 52 adapted for positioning in an environment selectedfrom a body of an organism, a body of water or other fluid, or acontained fluid volume. In some embodiments, the body structure may beadapted for positioning in a contained fluid volume selected from anindustrial fluid volume, an agricultural fluid volume, a swimming pool,an aquarium, a drinking water supply, and an HVAC system cooling watersupply. Various embodiments may be used in connection with selectedbiomedical applications (e.g., with osmotic pump devices adapted forplacement in the body of a human or other animal). It is alsocontemplated that osmotic pump systems as described herein may be usedin a variety of environments, not limited to the bodies of humans orother animals. Osmotic pump devices may be placed in other types ofliving organisms (e.g., plants). Osmotic pump devices may also be placedin bodies of water, or in various enclosed fluid volumes, in industrial,agricultural, and various other types of applications. The environmentsfor use of embodiments described herein are merely exemplary, and theosmotic pump systems as disclosed herein are not limited to use in theexemplary applications.

FIG. 18 illustrates an exemplary embodiment of an osmotic pump system800 in which an osmotic pump device 12 is located in a small enclosedfluid volume 802 (e.g., an aquarium). A remote controller or remotecontrol signal generator 16 is located outside enclosed fluid volume802.

FIG. 19 illustrates a further exemplary embodiment of an osmotic pumpsystem 804 in which an osmotic pump device 12 is located in a largerenclosed fluid volume 806 (which may be, for example, a water storagetank, an HVAC system cooling water tank, a tank containing an industrialfluid or an agricultural fluid). A remote controller or remote controlsignal generator 16 is located outside enclosed fluid volume 1001.

FIG. 20 illustrates a further exemplary embodiment of an osmotic pumpsystem 808 in which an osmotic pump device 12 is located in a body ofwater 810 (a lake or pond is depicted here, but such osmotic pumpsystems may also be designed for use in rivers, streams, or oceans). Theremote controller or remote control signal generator 16 is shown locatedoutside of body of water 810, though in some embodiments it may beadvantageous to place remote controller 16 at a location within body ofwater 810.

A wide variety of materials may be stored in a delivery reservoir ofosmotic pump devices as described herein, and the choice of materialwill depend upon the use environment and intended application for theosmotic pump device. Materials which may be delivered into anenvironment by an osmotic pump device may include, but are not limitedto, fertilizers, nutrients, remediation agents,antibiotics/microbicides, herbicides, fungicides, disinfectants,materials for adjusting a chemical composition or pH, such as buffers,acides, bases, chelating agents, and surfactant, etc. Examples ofmaterials that may be delivered into the body of an organism includenutrients, hormones, growth factors, medications, therapeutic compounds,enzymes, genetic materials, vaccines, vitamins, imaging agents,cell-signaling materials, pro- or anti-apoptotic agents, orneurotransmitters. Materials may also include precursors or componentsof certain materials such as genetic materials, vaccines, nutrients,vitamins, imaging agents, therapeutic compounds, hormones, growthfactors, pro- or anti-apoptotic agents, or neurotransmitters. Suchprecursors, may include, for example, prodrugs (see, e.g.,“Liver-Targeted Drug Delivery Using HepDirect1 Prodrugs,” Erion et al.,Journal of Pharmacology and Experimental Therapeutics Fast Forward, JPET312:554-560, 2005 (first pub Aug. 31, 2004) and “LEAPT: Lectin-directedenzyme-activated prodrug therapy”, Robinson et al., PNAS Oct. 5, 2004vol. 101, No. 40, 14527-14532, published online before print Sep. 24,2004 (http://www.pnas.org/cgi/content/full/101/40/14527), both of whichare incorporated herein by reference. Beneficial materials may beproduced, for example, by conversion of pro-drug to drug, enzymaticreaction of material in bloodstream (CYP450, cholesterol metabolism,e.g., with cholesterol monooxygenase, cholesterol reductase, cholesteroloxidase). The term “delivery fluid” as used herein, is intended tocovery materials having any form that exhibits fluid or fluid-likebehavior, including liquids, gases, powders or other solid particles ina liquid or gas carrier. The delivery fluid may be a solution,suspension, or emulsion. Materials to be delivered into the environmentmay have suitable fluid properties in some cases, while in other casesthe material of interest may be delivered in a fluid solvent or carrier,in solution, suspension, or emulsion, as noted above, or in a gaseous orsolid carrier material.

An osmotic pump device as depicted in FIG. 17 may include a remotelyactivatable control element responsive to the electromagnetic fieldcontrol signal to control the generation of osmotic pressure by theosmotic pressure-generating material. The remotely activatable controlelement may include a magnetically or electrically active materialincluding at least one of a permanently magnetizable material, aferromagnetic material, a ferrimagnetic material, a ferrous material, aferric material, a dielectric or ferroelectric or piezoelectricmaterial, a diamagnetic material, a paramagnetic material, and anantiferromagnetic material. The remotely activatable control element mayinclude a polymer, ceramic, dielectric or metal. In some embodiments,the osmotic pump system may include a shape memory material. In someembodiments, the remotely activatable control element may include apolymer and a magnetically or electrically active component.

In some embodiments, the remotely activatable control element mayrespond to the control signal by changing shape. In some embodiments,the remotely activatable control element may respond to the controlsignal by changing in at least one dimension. The response of theremotely activatable control element may include one or more of heating,cooling, vibrating, expanding, stretching, unfolding, contracting,deforming, softening, or folding globally or locally. The remotelyactivatable control element may include various materials, such aspolymers, ceramics, plastics, dielectrics or metals, or combinationsthereof. The remotely activatable control element may include a shapememory material such as a shape memory polymer or a shape memory metal,or a composite structure such as a bimetallic structure. The remotelyactivatable control element may include a magnetically or electricallyactive material. Examples of magnetically active materials includepermanently magnetizable materials, ferromagnetic materials such asiron, nickel, cobalt, and alloys thereof, ferrimagnetic materials suchas magnetite, ferrous materials, ferric materials, diamagnetic materialssuch as quartz, paramagnetic materials such as silicate or sulfide, andantiferromagnetic materials such as canted antiferromagnetic materialswhich behave similarly to ferromagnetic materials; examples ofelectrically active materials include ferroelectrics, piezoelectrics anddielectrics having both positive and negative real permittivities. Insome embodiments, the remotely activatable control element may include ahydrogel or a ferrogel.

In some embodiments, the remotely activatable control element mayinclude a polymer and an electrically active component (including highlypolarizable dielectrics) or a magnetically active component (includingferropolymers and the like) as well as remotely activatable controlelements including one (or possibly more) large magnetically orelectrically active components. In embodiments in which the remotelyactivatable control element includes one or more electrically ormagnetically active components, the electrically or magnetically activecomponent may respond to an electromagnetic control signal in a firstmanner (e.g., by heating) and the response of the remotely activatablecontrol element may be produced in response to the electrically ormagnetically active component (e.g. expansion or change in shape inresponse to heating of the electrically or magnetically activecomponent).

Various types and frequencies of electromagnetic control signals may beused in osmotic pump systems as described herein. For example, in someembodiments, the osmotic pump system may include a remote control signalsource configured to generate a static or quasi-static electrical fieldcontrol signal or static or quasi-static magnetic field controlsufficient to activate the remotely activatable control element tocontrol the generation of osmotic pressure in a desired manner. In otherembodiments, the remote control signal source may be configured togenerate a radio-frequency, microwave, infrared, millimeter wave,optical, or ultraviolet electromagnetic field control signal sufficientto activate the remotely activatable control element to control thegeneration of osmotic pressure in a desired manner.

A remote controller for an osmotic pump device may include anelectromagnetic signal generator capable of producing an electromagneticsignal sufficient to activate a remotely activatable control element ofan osmotic pump device located in an environment to change aconcentration of an osmotic pressure-generating material within anosmotic chamber of the osmotic pump device; and an electromagneticsignal transmitter capable of wirelessly transmitting theelectromagnetic signal to the remotely activatable control element.

Referring back to FIG. 17, signal transmitter 764 may include a sendingdevice which may be, for example, an antenna or waveguide suitable foruse with an electromagnetic signal. Static and quasistatic electricalfields may be produced, for example, by charged metallic surfaces, whilestatic and quasistatic magnetic fields may be produced, for example, bypassing current through one or more wires or coils, or through the useof one or more permanent magnets, as known to those of skill in the art.As used herein, the terms transmit, transmitter, and transmission arenot limited to only transmitting in the sense of radiowave transmissionand reception of electromagnetic signals, but are also applied towireless coupling and/or conveyance of magnetic signals from one or moreinitial locations to one or more remote locations.

The remote control signal source 754 as depicted generally in FIG. 17may be configured to produce an electromagnetic control signal havingvarious characteristics, depending upon the intended application of thesystem. In some embodiments, a specific remote control signal source maybe configured to produce only a specific type of signal (e.g., of aspecific frequency or frequency band) while in other embodiments, aspecific remote control signal source may be adjustable to produce asignal having variable frequency content. Signals may include componentswhich contribute a DC bias or offset in some cases, as well as ACfrequency components. The remote control signal source 754 of theosmotic pump system 750 may be configured to generate a static orquasi-static electrical field control signal or static or quasi-staticmagnetic field control signal sufficient to activate a remotelyactivatable control element 18 to produce a desired osmotic pressure orpumping rate. In other embodiments, the remote control signal source 754may be configured to generate an electromagnetic control signal atvarious different frequencies sufficient to activate the remotelyactivatable control element 18 to produce a desired rate or kinetics ofthe chemical reaction. Electromagnetic control signals may haveradio-frequency, microwave, infrared, millimeter wave, optical, orultraviolet frequencies, for example. Generation of radio frequencyelectromagnetic signals is described, for example, in the The ARRLHandbook for Radio Communications 2006, R. Dean Straw, Editor, publishedby ARRL, Newington, Conn., which is incorporated herein by reference.

The remote controller/remote control signal source (e.g., 754 in FIG.17) may be modified as appropriate for its intended use. For example, itmay be configured to be wearable on the body of a human (or otherorganism) in which an osmotic pump device has been deployed, for exampleon a belt, bracelet or pendant, or taped or otherwise adhered to thebody of the human. Alternatively, it may be configured to be placed inthe surroundings of the organism, e.g., as a table-top device for use ina home or clinical setting.

Various types of electromagnetic field control signals may be used toactivate the remotely activatable control element. The remotelyactivatable control element may be responsive to a static orquasi-static electrical field or a static or quasi-static magneticfield. It may be responsive to various types of non-ionizingelectromagnetic radiation, or in some cases, ionizing electromagneticradiation. Electromagnetic field control signals that may be used invarious embodiments include radio-frequency electromagnetic radiation,microwave electromagnetic radiation, infrared electromagnetic radiation,millimeter wave electromagnetic radiation, optical electromagneticradiation, or ultraviolet electromagnetic radiation.

The electromagnetic signal generator may include electrical circuitryand/or a microprocessor. In some embodiments, the electromagnetic signalmay be produced at least in part according to a pre-determinedactivation pattern. The remote controller may include a memory capableof storing the pre-determined activation pattern. In some embodiments,the electromagnetic signal may be produced based on a model-basedcalculation; the remote controller may include a memory capable ofstoring model parameters used in the model-based calculation.

FIG. 21 illustrates an osmotic pump system including a remote controller1050 that produces electromagnetic control signal 1052 that istransmitted to osmotic pump device 1054 in environment 1056.Electromagnetic control signal 1052 is received by remotely activatablecontrol element 1058 in osmotic pump device 1054. Remote controller 1050may include a signal input 1051 adapted for receiving a feedback signal1060 sensed from an environment 1056 by a sensor 1062, wherein theelectromagnetic signal 1052 is produced based at least in part upon thefeedback signal 1060 sensed from the environment. For example, thefeedback signal 1052 may correspond to the osmolality or the pH of theenvironment, the concentration or chemical activity of a chemical in theenvironment, a temperature or pressure of the environment, or some othersensed signal. Remote controller 1050 may include electrical circuitry1064, signal generator 1066, signal transmitter 1068, and memory 1070.Feedback from sensor 1062 may be sent over a wire connection or, in someembodiments, transmitted wirelessly.

FIG. 22 illustrates another embodiment of an osmotic pump system,including remote controller 1100, which transmits electromagneticcontrol signal 1102 to osmotic pump device 1104 in environment 1106.Remote controller 1100 may include a signal input 1108 adapted forreceiving a feedback signal 1112 from sensor 1110 in osmotic pump device1104. The electromagnetic signal 1102 may be determined based at leastin part upon the feedback signal 1112. Examples of sensors are describedin U.S. Pat. No. 6,935,165, and U.S. Patent Publication 2004/0007051,both of which are incorporated herein by reference. Osmotic pump device1104 includes remotely activatable control element 1058. Feedback signal1112 may be transmitted wirelessly back to remote controller 1100.Remote controller 1100 may include processor 1114, signal generator1116, signal transmitter 1118, and memory 1120. In some embodiments, theremote controller 1100 may include a signal input 1108 adapted forreceiving a feedback signal from the osmotic pump device, wherein theelectromagnetic signal is produced based at least in part upon thefeedback signal sensed from the osmotic pump device. A feedback signalfrom the osmotic pump device may correspond to the osmolality or the pHwithin or around the osmotic pump device, the concentration or chemicalactivity of a chemical within or around the osmotic pump device, atemperature or pressure within or around the osmotic pump device, thepumping rate of the osmotic pump device, or some other parameter sensedfrom the osmotic pump device.

As illustrated in FIG. 23, in some embodiments, the remote controllermay be configured to receive user input of control parameters. Remotecontroller 1150 includes input 1160 for receiving input of informationor instructions from a user such as, for example, commands, variables,durations, amplitudes, frequencies, waveforms, data storage or retrievalinstructions, patient data, etc. As in the other embodiments, remotecontroller 1150 transmits electromagnetic control signal 1152 to osmoticpump device 1154 in environment 1156, where it activates remotelyactivatable control element 1158. Input 1160 may include one or moreinput devices such as a keyboard, keypad, microphone, mouse, etc. fordirect input of information from a user, or input 1160 may be any ofvarious types of analog or digital data inputs or ports, including dataread devices such as disk drives, memory device readers, and so forth inorder to receive information or data in digital or electronic form. Dataor instructions entered via input 1160 may be used by electricalcircuitry 1162 to modify the operation of remote controller 1150 tomodulate generation of an electromagnetic control signal 1152 by signalgenerator 1164 and transmission of the control signal 1152 bytransmitter 1166.

In this an other embodiment disclosed herein, the remote controller mayinclude software, which may include, for example, instructions forcontrolling the generation of the electromagnetic control signal andinstructions for controlling the transmission of the electromagneticcontrol signal to the electromagnetically responsive control element.

Osmotic pump devices as disclosed herein may be controlled by a methodas illustrated in FIG. 24, which may include generating anelectromagnetic control signal including frequency components absorbableby a magnetically or electrically responsive control element of theosmotic pump device in an environment, at step 1202, and remotelytransmitting the electromagnetic control signal to the osmotic pumpdevice with signal characteristics sufficient to activate themagnetically or electrically responsive control element in the osmoticpump device to control the concentration of an osmotic-pressuregenerating material in the osmotic pump device, at step 1204.

The method as depicted generally in FIG. 24 may include generating andtransmitting the electromagnetic control signal to the osmotic pumpdevice with a remote control signal source. Generating anelectromagnetic control signal may include generating theelectromagnetic control signal from a model-based calculation orgenerating the electromagnetic control signal based on a stored pattern.As shown in FIG. 25, in addition to steps of generating anelectromagnetic control signal including frequency components absorbableby a magnetically or electrically responsive control element of theosmotic pump device in an environment, at 1222, and remotelytransmitting the electromagnetic control signal to the osmotic pumpdevice with signal characteristics sufficient to activate themagnetically or electrically responsive control element in the osmoticpump device to control the concentration of an osmotic-pressuregenerating material in the osmotic pump device, at 1224. The method mayalso include receiving a feedback signal from the environment at step1226 and, based upon the feedback signal, generating the electromagneticcontrol signal with signal characteristics expected to produce a desiredfeedback signal at step 1228. The method steps may be repeated until adecision to quit is made a decision point 1230. Receiving a feedbacksignal from the environment may include receiving a measure ofosmolality, pH, temperature, pressure or concentration or chemicalactivity of a chemical within at least a portion of the environment.

As shown in FIG. 26, the method may include generating anelectromagnetic control signal including frequency components absorbableby a magnetically or electrically responsive control element of theosmotic pump device in an environment, at step 1302, remotelytransmitting the electromagnetic control signal to the osmotic pumpdevice with signal characteristics sufficient to activate themagnetically or electrically responsive control element in the osmoticpump device to control the concentration of an osmotic-pressuregenerating material in the osmotic pump device, at 1304, receiving afeedback signal from the osmotic pump device at step 1306, and basedupon the feedback signal, generating an electromagnetic control signalhaving signal characteristics that are expected to produce a desiredfeedback signal at step 1308. As noted in connection with other relatedembodiments, the method steps may be repeated until a decision to quitis made a decision point 1310. Receiving a feedback signal from theosmotic pump device may include receiving a signal representing aconcentration of osmotic pressure-generating material within the osmoticpump device, the concentration or chemical activity of a chemical withinor around the osmotic pump device, or the osmolality, pH, temperature,or pressure within or around the osmotic pump device.

In some embodiments, as shown in FIG. 27, the method may includereceiving user input of one or more control parameters at step 1352, andbased upon the one or more control parameters, generating anelectromagnetic control signal including frequency components absorbableby a magnetically or electrically responsive control element of theosmotic pump device in an environment, the electromagnetic controlsignal having signal characteristics expected to produce a desiredconcentration of osmotic-pressure generating material in the osmoticpump device, at step 1354. The method also may include step 1356,including remotely transmitting the electromagnetic control signal tothe osmotic pump device with signal characteristics sufficient toactivated the magnetically or electrically responsive control element inthe osmotic pump device to control the concentration of an osmoticpressure-generating material in the osmotic pump device. The desiredconcentration of osmotic pressure generating material in the osmoticpump device may be a concentration sufficient to produce a desiredpumping rate by the osmotic pump device. The method may includeactivating the magnetically or electrically responsive control elementto produce heating or cooling, or to produce a change in configurationof the magnetically or electrically responsive control element.

In some embodiments, the steps of generating an electromagnetic controlsignal and remotely transmitting the electromagnetic control signal tothe osmotic pump device may be performed according to instructionsprovided in the form of software, hardware or firmware. Generating theelectromagnetic control signal may include generating a static orquasi-static magnetic field, static or quasi-static electrical field, orradio-frequency, microwave, infrared, optical, or ultraviolet wavelengthelectromagnetic signal. The method may include generating theelectromagnetic control signal under software control. The method mayinclude modifying the concentration of the osmotic pressure-generatingmaterial within an osmotic chamber of the osmotic pump device bymodifying the area of an interaction region within the osmotic chamber.Modifying the area of the interaction region may include increasing thearea of the interaction region, which may include one or both ofincreasing the distances between interaction sites in the interactionregion and increasing the number of available interaction sites in thereaction area. Conversely, modifying the area of the interaction regionmay include decreasing the area of the interaction region, which mayinclude decreasing the distances between interaction sites in theinteraction region and/or decreasing the number of available interactionsites in the reaction area.

Modifying the concentration of the osmotic pressure-generating materialwithin an osmotic chamber of the osmotic pump device may includemodifying a condition at an interaction region within the osmoticchamber, which may include, for example, heating or cooling at least aportion of the interaction region. Alternatively, or in addition,modifying a condition at the interaction region may include modifyingthe osmolality or the pH of at least a portion of the interactionregion, or modifying the surface charge or surface energy of at least aportion of the interaction region. Modifying a condition at theinteraction region may include modifying a condition within the osmoticchamber, such as modifying the volume of the osmotic chamber, heating orcooling at least a portion of the osmotic chamber, or modifying theosmolality or the pH within at least a portion of the osmotic chamber.

A further method of controlling an osmotic pump device is depicted inFIG. 28, which includes generating an electromagnetic control signalincluding frequency components absorbable by a magnetically orelectrically responsive control element of the osmotic pump device in anenvironment at step 1372, and remotely transmitting the electromagneticcontrol signal to the osmotic pump device in the environment with signalcharacteristics sufficient to produce mechanical, thermal or chemicalactivation of the magnetically or electrically responsive controlelement in the osmotic pump device to control the pumping rate of theosmotic pump device at step 1374. The method may include generating andtransmitting the electromagnetic control signal with a remote controlsignal source. As in other described embodiments, the method may includegenerating the electromagnetic control signal from a model-basedcalculation or from a stored pattern. The method may also includereceiving a feedback signal from the environment, and based at least inpart upon the feedback signal, generating an electromagnetic controlsignal having signal characteristics expected to produce a desiredfeedback signal. Receiving a feedback signal from the environment mayinclude receiving a measure of osmolality, pH, temperature, pressure, orconcentration or chemical activity of a chemical within at least aportion of the environment.

Alternatively, or in addition, the method may include receiving afeedback signal from the osmotic pump device; and based at least in partupon the feedback signal, generating an electromagnetic control signalhaving signal characteristics expected to produce a desired feedbacksignal. Receiving a feedback signal from the osmotic pump device mayinclude receiving a signal representing a concentration or a chemicalactivity of a material at an interaction region within an osmoticchamber of the osmotic pump device. The signal may represent theconcentration or chemical activity of an osmotic pressure-generatingmaterial, for example. The method may include receiving user input ofone or more control parameters, and based at least in part upon the oneor more control parameters, generating an electromagnetic control signalhaving signal characteristics expected to produce a desired pumping rateof the osmotic pump device. The method may include activating themagnetically or electrically responsive control element to produceheating or cooling, wherein the heating or cooling modifies aninteraction at an interaction region of the osmotic pump device andwherein the interaction modifies the osmotic pressure in the osmoticpump device, or activating the magnetically or electrically responsivecontrol element to produce a change in configuration of the magneticallyor electrically responsive control element, wherein the change inconfiguration modifies an interaction at an interaction region of theosmotic pump device and wherein the interaction modifies the osmoticpressure in the osmotic pump device. Such a change in configuration mayinclude expansion or contraction of the magnetically or electricallyresponsive control element. Expansion may cause exposure of interactionsites at the interaction region, or change the density of interactionsites at the interaction region. In cases where the magnetically orelectrically responsive control element includes a polymer, theexpansion of the magnetically or electrically responsive control elementmay cause opening of pores in the polymer. A change in configuration mayinclude a change in shape of a magnetically or electrically responsivecontrol element.

In some embodiments, the steps of generating an electromagnetic controlsignal and of remotely transmitting the electromagnetic control signalto the osmotic pump device may be performed according to instructionsprovided in the form of software, hardware or firmware. Software forcontrolling an osmotic pump device may include, for example,instructions for generating an electromagnetic control signal includingfrequency components absorbable by a magnetically or electricallyresponsive control element of the osmotic pump device in an environment,and instructions for remotely transmitting the electromagnetic controlsignal to the osmotic pump device in the environment with signalcharacteristics sufficient to produce at least one of mechanical,thermal or chemical activation of the magnetically or electricallyresponsive control element in the osmotic pump device to control thepumping rate of osmotic pump device. The instructions for generating theelectromagnetic control signal may include instructions for calculatingthe electromagnetic control signal based on a model, and/or forgenerating the electromagnetic control signal based on a pattern storedin a data storage location.

The software may also include instructions for receiving a feedbacksignal from the environment and instructions for generating theelectromagnetic control signal based at least in part upon the receivedfeedback signal, the electromagnetic control signal having signalcharacteristics expected to produce a desired feedback signal. In somesoftware embodiments, the software may also include instructions forreceiving a feedback signal from the osmotic pump device and forgenerating the electromagnetic control signal based at least in part onthe received feedback signal, the electromagnetic control signal havingfrequency composition and amplitude expected to produce a desiredfeedback signal. The software may include instructions for receivinguser input of one or more control parameters and instructions forgenerating the electromagnetic control signal based at least in partupon the one or more control parameters.

The remote controller may produce an electromagnetic signal having oneor both of a defined magnetic field strength or defined electric fieldstrength. In general, the term field strength, as applied to eithermagnetic or electric fields, may refer to field amplitude,squared-amplitude, or time-averaged squared-amplitude. Theelectromagnetic signal may have signal characteristics sufficient toproduce a change in dimension of the remotely activatable controlelement, a change in temperature of the remotely activatable controlelement, a change in conformation of the remotely activatable controlelement, or a change in orientation or position of the remotelyactivatable control element. In some embodiments, the electromagneticsignal generator may include an electromagnet orelectrically-polarizable element, or at least one permanent magnet orelectret. The electromagnetic signal may be produced at least in partaccording to a pre-programmed pattern. The electromagnetic signal mayhave signal characteristics sufficient to produce a change in dimensionin the remotely activatable control element, the change in dimensioncausing a change in the concentration of the osmotic pressure-generatingmaterial within the osmotic chamber of the osmotic pump device. It mayhave signal characteristics sufficient to produce a change intemperature of the remotely activatable control element, the change intemperature causing a change in the concentration of the osmoticpressure-generating material within the osmotic chamber of the osmoticpump device. In some embodiments, it may have signal characteristicssufficient to produce a change in one or more of shape, volume, surfacearea or configuration of the remotely activatable control element, thechange in dimension in one or more of shape, volume, surface area orconfiguration of the remotely activatable control element causing achange in the concentration of the osmotic pressure-generating materialwithin the osmotic chamber of the osmotic pump device. Theelectromagnetic signal may have signal characteristics sufficient toproduce a change in shape in a remotely activatable control elementincluding a shape memory material, a bimetallic structure, or apolymeric material. The electromagnetic signal may have a definedmagnetic field strength or spatial orientation, or a defined electricfield strength or spatial orientation.

The electromagnetic control signal may be produced based at least inpart upon a predetermined activation pattern. As shown in FIG. 29, apredetermined activation pattern may include a set of stored data 1402a, 1402 b, 1402 c, 1402 d, . . . 1402 e, having values f(t₁), f(t₂),f(t₃), f(t₄), . . . f(t_(N)), stored in a memory location 1400. Theactivation pattern upon which the electromagnetic signal is based isdepicted in plot 1404 in FIG. 29. In plot 1404, time t_(n) is indicatedon axis 1406 and signal amplitude f(t_(n)), which is a function oft_(n), is indicated on axis 1408. The value of the electromagneticsignal over time is represented by trace 1410. The predeterminedactivation pattern represented by data 1402 a, 1402 b, 1402 c, 1402 d, .. . 1402 e may be based upon calculation, measurements, or any othermethod that may be used for producing an activation pattern suitable foractivating a remotely activatable control element. Memory 1400 may be amemory location in a remote controller. As an example, a simple remotecontroller may include a stored activation pattern in memory and includeelectrical circuitry configured to generate an electromagnetic controlsignal according to the pattern for a preset duration or at presetintervals, without further input of either feedback information or userdata. In a more complex embodiment, a predetermined activation patternmay be generated in response to certain feedback or user inputconditions.

An electromagnetic signal may also be produced based upon a model-basedcalculation. As shown in FIG. 30, an activation pattern f(t_(n)) may bea function not only of time (t_(n)) but also of model parameters P₁, P₂,. . . P_(k), as indicated by equation 1450. Data 1452 a, 1452 b, . . .1452 c having values P₁, P₂, . . . P_(k) may be stored in memory 1454.An electromagnetic control signal may be computed from the stored modelparameters and time information. For example, as indicated in plot 1456,time is indicated on axis 1458 and the strength or amplitude of theelectromagnetic control signal is indicated on axis 1460, so that trace1461 represents f(t_(n)). Memory 1454 may be a memory location in aremote controller. The remote controller may generate an electromagneticcontrol signal based upon the stored function and correspondingparameters. In some embodiments, the electromagnetic control signal mayalso be a function of one or more feedback signals (from the osmoticpump device or the environment, for example) or of some user input ofdata or instructions.

FIG. 31 depicts an example of an electromagnetic waveform. In plot 1550,time is plotted on axis 1552, and electromagnetic field strength isplotted on axis 1554. Trace 1556 has the form of a square wave,switching between zero amplitude and a non-zero amplitude, A.

FIG. 32 depicts another example of an electromagnetic waveform. In plot1600, time is plotted on axis 1602, and electromagnetic field strengthis plotted on axis 1604. Trace 1606 includes bursts 1608 and 1610,during which the field strength varies between A and −A, at a selectedfrequency, and interval 1612, during which field strength is zero.

FIG. 33 depicts another example of an electromagnetic waveform. In plot1650, time is plotted on axis 1652, and electromagnetic field strengthis plotted on axis 1654. Trace 1656 includes bursts 1658, and 1662,during which the field strength varies between A and −A at a firstfrequency, and burst 1660, during which the field strength variesbetween B and −B at a second (lower) frequency. Different frequenciesmay be selectively received by certain individuals or classes ofremotely activatable control elements within a device or systemincluding multiple remotely activatable control elements. Anelectromagnetic control signal may be characterized by one or morefrequencies, phases, amplitudes, or polarizations. An electromagneticcontrol signal may have a characteristic temporal profile and direction,and characteristic spatial dependencies.

The magnetic or electric field control signal produced by the remotecontroller may have one or both of a defined magnetic field strength ora defined electric field strength. At low frequencies the electrical andmagnetic components of an electromagnetic field are separable when thefield enters a medium. Therefore, in static and quasi-static fieldapplication, the electromagnetic field control signal may be consideredas an electrical field or a magnetic field. A quasi-static field is onethat varies slowly, i.e., with a wavelength that is long with respect tothe physical scale of interest or a frequency that is low compared tothe characteristic response frequency of the object or medium;therefore, the frequency beyond which a field will no longer beconsidered ‘quasi-static’ is dependent upon the dimensions orelectrodynamic properties of the medium or structure(s) influenced bythe field.

FIG. 34 depicts a remote controller 1700 having a memory 1704 capable ofstoring pre-determined data values or parameters used in model-basedcalculation, as described in connection with FIGS. 29 and 30. Remotecontroller 1700 may also include electrical circuitry 1702, signalgenerator 1712, and signal transmitter 1714 for transmittingelectromagnetic control signal 1716, generally as described previously.Memory 1704 may include memory location 1706 for containing a storedactivation pattern or model parameters; portions of memory 1704 may alsobe used for storing operating system, program code, etc. for use byprocessor 1702. The controller 1700 may also include a beam director1718, such as an antenna, optical element, mirror, transducer, or otherstructure that may impact control of electromagnetic signaling.

The remote controller may include an electromagnetic signal generatorcapable of producing various types of control signals. The remotecontroller may include an electromagnetic signal generator configured togenerate a static or quasi-static electrical field control signal or astatic or quasi-static magnetic field control signal sufficient toactivate the remotely activatable control element to control theconcentration of the osmotic pressure-generating material within theosmotic chamber in a desired manner. Alternatively, the remotecontroller may include an electromagnetic signal generator configured togenerate a radio-frequency, microwave, infrared, millimeter wave,optical, or ultraviolet electromagnetic signal sufficient to activatethe remotely activatable control element to control the concentration ofthe osmotic pressure-generating material within the osmotic chamber in adesired manner.

In a further embodiment as exemplified in FIG. 35, an osmotic pumpdevice 1750 may include a housing 1752 configured for placement in anenvironment 1754; a delivery reservoir 1756 capable of containing adelivery fluid 1758; an osmotic chamber 1760; an osmoticpressure-generating material 1762 contained within the osmotic chamber1760; a pressure-responsive movable barrier 1764 separating the osmoticchamber 1760 from the delivery reservoir 1756, the pressure-responsivebarrier 1764 being substantially impermeable to the osmoticpressure-generating material 1762 and configured to move in response toa change in pressure in the osmotic chamber 1760 to produce a change inat least one of pressure or volume of the delivery reservoir 1756; asemi-permeable membrane 1766 separating the osmotic chamber 1760 from anosmotic fluid source (in this example, environment 1754), thesemi-permeable membrane being substantially permeable by fluid from theosmotic fluid source but substantially impermeable to the osmoticpressure-generating material 1762; and at least one remotelycontrollable valve 1768 configured to regulate the pumping of thematerial from the delivery reservoir in an on-going fashion responsiveto a time-varying electromagnetic field control signal. As depicted inFIG. 35, the remotely controllable valve 1768 may be located between theosmotic fluid source (environment 1754, via antechamber 1770) and theosmotic chamber 1760 to regulate the flow of osmotic fluid into theosmotic chamber 1760. Alternatively, as depicted in FIG. 36, a remotelycontrollable valve 1772 may be located downstream of the deliveryreservoir 1756 to regulate the flow of delivery fluid 1758 out of thedelivery reservoir. The delivery reservoir may include an outlet throughwhich the delivery fluid moves into the environment in response to thechange in at least one of pressure or volume in the delivery reservoir.

The remotely controllable valve (e.g. 1728 or 1772 in FIGS. 35 and 36,respectively) may include an electromagnetically responsive controlelement, which may, for example, include at least one of a permanentlymagnetizable material, a ferromagnetic material, a ferrimagneticmaterial, a ferrous material, a ferric material, a dielectric orferroelectric or piezoelectric material, a diamagnetic material, aparamagnetic material, and an antiferromagnetic material. Theelectromagnetically responsive control element may include a shapememory material, for example, a shape memory polymer or a shape memorymetal. In some embodiments, the electromagnetically responsive controlelement may include a bimetallic structure, polymer, ceramic, dielectricor metal, a hydrogel, a ferrogel or a ferroelectric. In someembodiments, the electromagnetically responsive control element may be acomposite structure, and may include, for example, a polymer and amagnetically or electrically active component. In some embodiments, theelectromagnetically responsive control element may include an expandingelement.

The osmotic pump device may include a valve responsive to a change in atleast one dimension of the remotely activatable control element. Thevalve may be formed in its entirety by the remotely activatable controlelement, or the remotely activatable control element may form only apart of the valve or the valve actuation mechanism. The remotelyactivatable control element may respond to the control signal bychanging in at least one dimension, and may include various materials,for example polymer, ceramic, dielectric or metal. For example, theremotely activatable control element may include a shape memory materialsuch as a shape memory polymer, a memory foam, or a shape memory alloysuch as nitinol (an alloy of titanium and nickel) or ferromagnetic shapememory materials (e.g., a Ni₂MnGa alloy). The remotely activatablecontrol element may include a bimetallic structure.

In the embodiment of an osmotic pumpt device depicted in FIG. 35, aremotely activatable valve/control element 1768 is formed from a shapememory material. The open position of the valve formed by remotelyactivatable control element 1768 is indicated by a solid line, while theclosed position is indicated by a dashed line.

In the embodiment of FIG. 36, valve 1772 is a remotely activatablecontrol element that may include an expandable gel structure, such ashydrogel or a ferrogel. The remotely activatable control element formsvalve 1772 for controlling the flow of fluid into the osmotic pumpdevice 1764, shown in its open (contracted) form by a solid line andshown in its closed (expanded) form by a dashed line. The osmoticpressure generated may be modified by adjusting the valve 1772 tocontrol the flow of fluid out of the osmotic pump device. An example ofa magnetically controlled hydrogel valve is described in “A temperaturecontrolled micro valve for biomedical applications using a temperaturesensitive hydrogel” Micro Total Analysis Systems Symposium, Nov. 3-7,Nara, Japan, 1: 142-144H. J. van der Linden, D. J. Beebe, and P.Bergveld (2002), incorporated herein by reference. Other potentialmaterials and structures for valves may be as described in U.S. Pat.Nos. 6,682,521, 6,755,621, 6,720,402, 6,607,553, which are incorporatedherein by reference.

In some embodiments, the osmotic fluid source may be the environment,while in other embodiments the osmotic fluid source may be a reservoiron the osmotic pump device. FIG. 37 depicts osmotic pump device 1950,including delivery reservoir 1952 containing delivery fluid 1954,osmotic chamber 1956 containing osmotic pressure-generating material1958, pressure-responsive movable barrier 1960, and semi-permeablebarrier 1962, all of which function as described previously. Osmoticpump device 1950 also includes collapsible reservoir 1964 containingosmotic fluid 1966. Collapsible reservoir 1964 is designed to collapseas osmotic fluid 1966 is drawn through semi-permeable barrier 1962. Flowof fluid out of delivery reservoir 1952 may be regulated by remotelyactivatable valve 1968.

FIG. 38 is a cross-sectional view of an embodiment of a valve 2000 inchannel 2002 defined by walls 2004 and including a remotely activatablevalve element 2006 positioned in a channel 2002. Valve element 2006 maybe a magnetically or electrically responsive element formed from, forexample, a ferropolymer or other material responsive to applied magneticor electric or electromagnetic fields or radiation. Valve element mayhave a first form 2006, indicated by the solid outline, when exposed toa first magnetic or electric field strength, and a second form 2006′,indicated by the dashed outline, when exposed to a second magnetic orelectric field strength. Valves of this type are disclosed, for example,in “A temperature controlled micro valve for biomedical applicationsusing a temperature sensitive hydrogel” Micro Total Analysis SystemsSymposium, Nov. 3-7, Nara, Japan, 1: 142-144, H. J. van der Linden, D.J. Beebe, and P. Bergveld (2002), incorporated herein by reference. Seealso U.S. Pat. Nos. 5,643,246, 5,830,207, and 6,755,621, which are alsoincorporated herein by reference. In first form 2006, valve element 2006obstructs channel 2002, blocking the flow of fluid through valve 2000.In its second form 2006′, valve element 2006 does not obstruct channel2002, and fluid flow through valve 2000 is unimpeded.

FIG. 39 is a cross-sectional view of an embodiment of another type ofvalve 2020, in which fluid channel 2022 defined by walls 2024 includes aremotely activatable valve element 2026. Remotely activatable valveelement 2026 is formed, for example from a bimetallic strip that changesfrom a first configuration to a second configuration during heatingproduced by exposure to a magnetic or electric or electromagnetic fieldor radation control signal. An open configuration of remotelyactivatable valve element 2026 is indicated by reference number 2026′.

In some valve embodiments, opening or closing of the valve may beproduced by a transient application of a magnetic or electric orelectromagnetic control signal, the control signal serving to causeswitching of the valve element from a first configuration to a secondconfiguration, while in other continuous application of a control signalmay be required to maintain the valve element in one of the twoconfigurations, with the valve element returning to the otherconfiguration upon removal of the control signal. Such a valve elementsmay be formed from a shape memory metal, a shape memory polymer, or abimetallic strip formed from laminated layer of metals having differentcoefficients of thermal expansion, for example. The construction of suchvalve elements is known to those of skill in the relevant arts, forexample.

In some embodiments, as illustrated in FIG. 40, an osmotic pump system2050 may include a downstream fluid handling structure 2052 in fluidcommunication with delivery reservoir 1756 and configured to receivedelivery fluid 1758 ejected from the delivery reservoir 1756 in responseto the change in at least one of pressure or volume in deliveryreservoir 1756. The downstream fluid handling structure 2052 may includeat least one of a channel or a chamber. The pressure-responsive movablebarrier 1764 may include a flexible membrane, for example as depicted inFIG. 40, or a piston, for example, as depicted in FIGS. 5A and 5B.Osmotic pump system 2050 also includes osmotic pressure generatingmaterial 1762, osmotic chamber 1760, and semi-permeable membrane 1766,e.g., as described in connection with FIGS. 35 and 36. The osmoticpressure-generating material may include ionic and non-ionicwater-attracting or water absorbing materials, non-volatilewater-soluble species, salts, sugars, polysaccharides, polymers,hydrogels, osmoopolymers, hydrophilic polymers, and absorbent polymers,examples of which are disclose herein.

An osmotic pump device of the type depicted in FIG. 35-37 or 40 may forma part of an osmotic pump system 2100 as shown in FIG. 41 that includesan osmotic pump device 2102 and a remote control signal source 2104capable of generating a time-varying electromagnetic field controlsignal 2106 sufficient to modify the concentration of osmoticpressure-generating material 2108 within the osmotic chamber 2110 of theosmotic pump 2102. As described previously, the osmotic pump device mayinclude a housing 2112 configured for placement in an environment, adelivery reservoir 2114 capable of containing a delivery fluid, anosmotic chamber 2110, an osmotic pressure-generating material 2108contained within the osmotic chamber 2110, a pressure-responsive movablebarrier 2118 separating the osmotic chamber from the delivery reservoir2114, the pressure-responsive barrier being substantially impermeable tothe osmotic pressure-generating material 2108 and configured to move inresponse to a change in pressure in the osmotic chamber 2110 to producea change in at least one of pressure or volume of the deliveryreservoir, a semi-permeable membrane 2120 separating the osmotic chamberfrom an osmotic fluid source, the semi-permeable membrane 2120 beingsubstantially permeable by fluid from the osmotic fluid source (e.g.environment 2122) but substantially impermeable to the osmoticpressure-generating material 2108, and at least one remotelycontrollable valve 2124 configured to regulate the pumping of thematerial from the delivery reservoir 2114 in an on-going fashionresponsive to a time-varying electromagnetic field control signal.Remote control signal source 2104 may include electrical circuitry 2125,signal generator 2126, and signal transmitter 2128, which may functionin the same fashion as the components of remote control signal source754 in FIG. 17, for example. The environment 2122 may be selected, forexample, from a body of an organism, a body of water, or a containedfluid volume

The remote control signal source 2104 may include at least one ofhardware, firmware, or software configured to control generation of theelectromagnetic control field signal. The remotely controllable valve2124 may include an electromagnetically responsive control element,which may include at least one of a permanently magnetizable material, aferromagnetic material, a ferrimagnetic material, a ferrous material, aferric material, a dielectric or ferroelectric or piezoelectricmaterial, a diamagnetic material, a paramagnetic material, and anantiferromagnetic material. The electromagnetically responsive controlelement may include a shape memory material such as a shape memorypolymer or a shape memory metal, or a bimetallic structure. Theelectromagnetically responsive control element includes a polymer,ceramic, dielectric or metal. The electromagnetically responsive controlelement may include at least one of a hydrogel, a ferrogel or aferroelectric, or a combination of a polymer and a magnetically orelectrically active component. An electromagnetically responsive controlelement includes an expanding element.

Remote control signal source 2104 may be configured to generate a staticor quasi-static electrical field control signal sufficient to activatethe remotely controllable valve to control the pumping of material fromthe delivery reservoir in a desired manner, or a static or quasi-staticmagnetic field control signal sufficient to activate the remotelycontrollable valve to control the pumping of material from the deliveryreservoir in a desired manner. In some embodiments, the remote controlsignal source may be configured to generate a radio-frequency,microwave, infrared, millimeter wave, optical, or ultravioletelectromagnetic field control signal sufficient to activate the remotelycontrollable valve to control the pumping of material from the deliveryreservoir in a desired manner.

A remote controller for an osmotic pump device may include anelectromagnetic signal generator capable of producing a time-varyingelectromagnetic field control signal sufficient to adjust a remotelycontrollable valve in an osmotic pump device located in an environmentto produce a desired time-varying pumping rate of delivery fluid from adelivery reservoir of the pump to the environment, the pumping ratedepending on the flow rate of fluid through the valve, and anelectromagnetic signal transmitter capable of transmitting theelectromagnetic signal to an electromagnetically responsive controlelement of the remotely controllable valve.

The electromagnetic signal generator may include electrical circuitryand/or a microprocessor. The electromagnetic signal may be produced atleast in part according to a pre-determined activation pattern, and theremote controller may include a memory capable of storing thepre-determined activation pattern. In addition, or as an alternative,the electromagnetic signal may be produced based on a model-basedcalculation, and the remote controller may include a memory capable ofstoring model parameters used in the model-based calculation. In someembodiments, the electromagnetic signal may be produced based at leastin part upon a feedback signal sensed from the environment.

The electromagnetic signal may have a defined magnetic field strength ordefined electric field strength. In some embodiments of the remotecontroller, the electromagnetic signal may have signal characteristicssufficient to produce a change in dimension in the electromagneticallyresponsive control element of the remotely controllable valve. Forexample, the electromagnetic signal may have signal characteristicssufficient to produce contraction in at least one dimension of theelectromagnetically responsive control element, or expansion in at leastone dimension of the electromagnetically responsive control element. Insome embodiments, the electromagnetic signal may have signalcharacteristics sufficient to produce a change in temperature, shape,volume, surface area, or orientation in the electromagneticallyresponsive control element. The electromagnetic signal may have signalcharacteristics sufficient to produce a change in shape in anelectromagnetically responsive control element comprising a shape memorymaterial; the shape memory material may be a shape memory metal or ashape memory polymer. Alternatively, the electromagnetic signal hassignal characteristics sufficient to produce a change in shape in anelectromagnetically responsive control element including a bimetallicstructure. The electromagnetic signal has signal characteristicssufficient to produce a change in shape in an electromagneticallyresponsive control element including a polymeric material.

As depicted in FIG. 42, in some embodiments of an osmotic pump system, aremote controller 2150 may include a signal input 2151 adapted forreceiving a feedback signal 2160 from sensor 2162 in the environment2122, wherein the electromagnetic signal 2152 is determined based atleast in part upon the feedback signal 2160. The feedback signal 2160may correspond to the concentration or chemical activity of a chemicalin the environment, or the osmolality, pH, temperature, or pressure ofthe environment. Remote controller 2150 may include electrical circuitry2164, signal generator 2166, signal transmitter 2168, and memory 2170,for example. Feedback from sensor 2162 may be sent over a wireconnection or, in some embodiments, transmitted wirelessly.

In some embodiments, as depicted in FIG. 43, a remote controller 2200may include a signal input 2208 adapted for receiving a feedback signal2212 from sensor 2210 in osmotic pump device 2204. Osmotic pump system2201 in FIG. 43 include remote controller 2200, which transmitselectromagnetic control signal 2202 to osmotic pump device 2204 inenvironment 2122. Feedback signal 2212 from the osmotic pump device maycorrespond to the osmolality or the pH within or around the osmotic pumpdevice, the concentration or chemical activity of a chemical within oraround the osmotic pump device, a temperature or pressure within oraround the osmotic pump device, the pumping rate of the osmotic pumpdevice, or some other parameter sensed from the osmotic pump device. Theelectromagnetic signal 2202 may be determined based at least in partupon the feedback signal 2212. Examples of sensors are described in,U.S. Pat. No. 6,935,165, and U.S. Patent Publication 2004/0007051, bothof which are incorporated herein by reference. Osmotic pump device 2204includes remotely activatable control element 2124. Feedback signal 2212may be transmitted wirelessly back to remote controller 2200. Remotecontroller 2200 may include electrical circuitry 2214, signal generator2216, signal transmitter 2218, and memory 2220. Signal generator 2216may be capable of producing an electromagnetic signal that includes astatic or quasi-static magnetic field, a static or quasi-staticelectrical field, non-ionizing electromagnetic radiation,radio-frequency electromagnetic radiation, microwave electromagneticradiation, millimeter wave electromagnetic radiation, opticalelectromagnetic radiation, or ultraviolet electromagnetic radiation.

As illustrated in FIG. 44, in some embodiments of osmotic pump systems,the remote controller may be configured to receive user input of controlparameters. Remote controller 2250 includes input 2260 for receivinginput of information or instructions from a user such as, for example,commands, variables, durations, amplitudes, frequencies, waveforms, datastorage or retrieval instructions, patient data, etc. As in the otherembodiments, remote controller 2250 transmits electromagnetic controlsignal 2252 to osmotic pump device 2254 in environment 2122, where itactivates remotely activatable control element 2124. Input 2260 mayinclude one or more input devices such as a keyboard, keypad,microphone, mouse, etc. for direct input of information from a user, orinput 2260 may be any of various types of analog or digital data inputsor ports, including data read devices such as disk drives, memory devicereaders, and so forth in order to receive information or data in digitalor electronic form. Data or instructions entered via input 2260 may beused by electrical circuitry 2262 to modify the operation of remotecontroller 2250 to modulate generation of an electromagnetic controlsignal 2252 by signal generator 2264 and transmission of the controlsignal 2252 by transmitter 2266.

A method of controlling an osmotic pump device is shown in FIG. 45. Themethod of controlling the osmotic pump device includes generating anelectromagnetic control signal including frequency components absorbableby an electromagnetically responsive control element of a remotelycontrollable valve, the valve configured to adjust the flow of fluidinto or out of the osmotic pump device at step 2302 and remotelytransmitting the electromagnetic control signal to the osmotic pumpdevice in the environment with signal characteristics sufficient toproduce mechanical, thermal or chemical activation of theelectromagnetically responsive control element in the remotelycontrollable valve of the osmotic pump device to control the pumpingrate of the osmotic pump device at step 2304. The method may includegenerating and transmitting the electromagnetic control signal with aremote control signal source. The electromagnetic control signal may begenerated from a model-based calculation or from a stored pattern.

As shown in FIG. 46, the method of controlling the osmotic pump devicemay include generating an electromagnetic control signal includingfrequency components absorbable by an electromagnetically responsivecontrol element of a remotely controllable valve, the valve configuredto adjust the flow of fluid into or out of the osmotic pump device atstep 2322, remotely transmitting the electromagnetic control signal tothe osmotic pump device in the environment with signal characteristicssufficient to produce mechanical, thermal or chemical activation of theelectromagnetically responsive control element in the remotelycontrollable valve of the osmotic pump device to control the pumpingrate of the osmotic pump device at step 2324, receiving a feedbacksignal from the environment at step 2326, and based at least in partupon the feedback signal, generating an electromagnetic control signalhaving signal characteristics expected to produce a desired feedbacksignal at step 2328. The process may repeat until a decision to quit ismade at decision point 2330. Receiving a feedback signal from theenvironment may include receiving a measure of osmolality, as shown atstep 2334, pH as shown at step 2336, temperature as shown at step 2338,pressure as shown at step 2340, or concentration or chemical activity ofa chemical within at least a portion of the environment as shown atsteps 2342 and 2344, respectively.

In some embodiments, as shown in FIG. 47, the method of controlling theosmotic pump device may include generating an electromagnetic controlsignal including frequency components absorbable by anelectromagnetically responsive control element of a remotelycontrollable valve, the valve configured to adjust the flow of fluidinto or out of the osmotic pump device at step 2352 and remotelytransmitting the electromagnetic control signal to the osmotic pumpdevice in the environment with signal characteristics sufficient toproduce mechanical, thermal or chemical activation of theelectromagnetically responsive control element in the remotelycontrollable valve of the osmotic pump device to control the pumpingrate of the osmotic pump device at step 2354. The method may alsoinclude receiving a feedback signal from the osmotic pump device at step2356, and based at least in part upon the feedback signal, generating anelectromagnetic control signal having signal characteristics expected toproduce a desired feedback signal at step 2358. The process may repeatuntil a decision to quit is made at decision point 2360. Receiving afeedback signal from the osmotic pump device may include receiving asignal representing a concentration of an osmotic pressure-generatingmaterial in an osmotic fluid within the osmotic pump device.

In some embodiments, as shown in FIG. 48, a method of controlling theosmotic pump device may include receiving user input of one or morecontrol parameters at step 2372. Step 2374 includes, based at least inpart upon the one or more control parameters, generating anelectromagnetic control signal including signal frequency componentsabsorbably by an electromagnetically responsive control element of aremotely controllable valve, the valve configured to adjust the flow offluid into or out of the osmotic pump device, and the electromagneticcontrol signal having signal characteristics expected to produce adesired rate of pumping by the osmotic pump device. Step 2376 includesremotely transmitting the electromagnetic control signal to the osmoticpump device in the environment with signal characteristics sufficient toproduce mechanical, thermal, or chemical activation of theelectromagnetically responsive control element in the remotelycontrollable valve of the osmotic pump device to control the pumpingrate of the osmotic pump device.

In any or all of the embodiments, the method may include activating theelectromagnetically responsive control element to produce heating orcooling, wherein the heating or cooling modifies flow rate of fluidthrough the remotely controllable valve, or activating theelectromagnetically responsive control element to produce a change inconfiguration of the electromagnetically responsive control element,wherein the change in configuration modifies the flow rate of fluidthrough the remotely controllable valve.

The steps of generating an electromagnetic control signal and remotelytransmitting the electromagnetic control signal to the osmotic pumpdevice may be performed according to instructions provided in the formof software, hardware or firmware. Software for controlling the osmoticpump device may include instructions for generating an electromagneticcontrol signal including frequency components absorbable by anelectromagnetically responsive control element of a remotelycontrollable valve, the valve configured to adjust the flow of fluidinto or out of the osmotic pump device, and instructions for remotelytransmitting the electromagnetic control signal to the osmotic pumpdevice in the environment with signal characteristics sufficient toproduce mechanical, thermal or chemical activation of theelectromagnetically responsive control element in the remotelycontrollable valve of the osmotic pump device to control the pumpingrate of the osmotic pump device.

The software instructions for generating an electromagnetic controlsignal may include instructions for calculating the electromagneticcontrol signal based on a model, or instructions for generating theelectromagnetic control signal based on a pattern stored in a datastorage location. The software may include instructions for receiving afeedback signal from the environment, and instructions for generatingthe electromagnetic control signal based at least in part upon thereceived feedback signal, the electromagnetic control signal havingsignal characteristics expected to produce a desired feedback signal.Alternatively, or in addition, the software may include instructions forreceiving a feedback signal from the osmotic pump device andinstructions for generating the electromagnetic control signal basedupon at least in part on the received feedback signal, theelectromagnetic control signal having frequency composition andamplitude expected to produce a desired feedback signal. In someembodiments, the software may include instructions for receiving userinput of one or more control parameters and instructions for generatingthe electromagnetic control signal based at least in part upon the oneor more control parameters.

Osmotic pump devices as described herein may include one or multipleremotely activatable control elements. In devices that include multipleremotely activatable control elements, the multiple remotely activatablecontrol elements may all be of the same type, or may be of differenttypes. Multiple remotely activatable control elements may be activatedor controlled in parallel as exemplified in FIG. 49, or in series asexemplified in FIG. 50. In FIG. 49, osmotic pump device 2400 includesfirst osmotic pump 2402 and second osmotic pump 2404. Osmotic pumps 2402and 2404 are regulated by remotely activatable control elements 2406 and2408, respectively. Osmotic pumps 2402 and 2404 may be operated inparallel to pump two reactant fluids into chamber 2410, which may be areaction chamber in which the reactant fluids react prior to releaseinto the environment.

In FIG. 50, osmotic pump device 2450 includes first osmotic pump 2452controlled by first remotely activatable control element 2454, andsecond osmotic pump 2456 controlled by second remotely activatablecontrol element 2458. First osmotic pump 2452 may pump a fluid into areaction chamber 2460 to react with a reactant already present inreaction chamber 2460, for example, and subsequently into chamber 2462,where it may react with fluid pumped into chamber 2462 by second osmoticpump 2456. The osmotic pump systems depicted in FIGS. 49 and 50 aremerely exemplary of a large variety of systems that may be constructedincluding remotely activatable osmotic pumps.

Selective activation or control of remotely activatable control elementsmay be achieved by configuring remotely activatable control elements tobe activated by electromagnetic control signals having particular signalcharacteristics, which may include, for example, particular frequency,phase, amplitude, temporal profile, polarization, and/or directionalcharacteristics, and spatial variations thereof. For example, differentcontrol elements may be responsive to different frequency components ofa control signal, thereby allowing selective activation of the differentcontrol elements. An osmotic pump device may include multipleselectively activatable control elements, each associated with aparticular fluid handling element, which may thus be controlled toperform multiple fluid-handling or reaction steps in a particularsequence. It is also contemplated that an osmotic pump system mayinclude multiple osmotic pump devices which may be of the same ordifferent types. As shown in FIG. 51, an osmotic pump system 2500 mayinclude multiple identical osmotic pump devices 2502 distributedthroughout an environment 2504 in order to perform a particular chemicalreaction or process at multiple locations within the environment, andcontrolled by a remote controller 2506. Alternatively, an osmotic pumpsystem may include multiple different osmotic pump devices at differentlocations within an environment, each performing or controlling areaction suited for the particular location. The invention as describedherein is not limited to devices or systems including any specificnumber or configuration of remotely activatable control elements withinan osmotic pump device, or specific number or configuration of osmoticpump devices or remote controllers within an osmotic pump system.Depending upon the particular application of a system, remotelyactivatable control elements and/or osmotic pump devices may becontrolled in a particular pattern to producing a desired distributionof a delivery material in an environment. Control of such systems may beperformed with the use of suitable hardware, firmware, software, throughone or multiple remote controllers.

With regard to the hardware and/or software used in the control ofosmotic pump devices and systems according to the present embodiments,and particularly to the sensing, analysis, and control aspects of suchsystems, those having skill in the art will recognize that the state ofthe art has progressed to the point where there is little distinctionleft between hardware and software implementations of aspects ofsystems; the use of hardware or software is generally (but not always,in that in certain contexts the choice between hardware and software canbecome significant) a design choice representing cost vs. efficiency orimplementation convenience tradeoffs. Those having skill in the art willappreciate that there are various vehicles by which processes and/orsystems described herein can be effected (e.g., hardware, software,and/or firmware), and that the preferred vehicle will vary with thecontext in which the processes are deployed. For example, if animplementer determines that speed and accuracy are paramount, theimplementer may opt for a hardware and/or firmware vehicle;alternatively, if flexibility is paramount, the implementer may opt fora solely software implementation; or, yet again alternatively, theimplementer may opt for some combination of hardware, software, and/orfirmware. Hence, there are several possible vehicles by which theprocesses described herein may be effected, none of which is inherentlysuperior to the other in that any vehicle to be utilized is a choicedependent upon the context in which the vehicle will be deployed and thespecific concerns (e.g., speed, flexibility, or predictability) of theimplementer, any of which may vary.

The foregoing detailed description has set forth various embodiments ofthe devices and/or processes via the use of block diagrams, flowcharts,and/or examples. Insofar as such block diagrams, flowcharts, and/orexamples contain one or more functions and/or operations, it will beimplicitly understood by those with skill in the art that each functionand/or operation within such block diagrams, flowcharts, or examples canbe implemented, individually and/or collectively, by a wide range ofhardware, software, firmware, or virtually any combination thereof. Inone embodiment, several portions of the subject matter subject matterdescribed herein may be implemented via Application Specific IntegratedCircuits (ASICs), Field Programmable Gate Arrays (FPGAs), digital signalprocessors (DSPs), or other integrated formats. However, those skilledin the art will recognize that some aspects of the embodiments disclosedherein, in whole or in part, can be equivalently implemented in standardintegrated circuits, as one or more computer programs running on one ormore computers (e.g., as one or more programs running on one or morecomputer systems), as one or more programs running on one or moreprocessors (e.g., as one or more programs running on one or moremicroprocessors), as firmware, or as virtually any combination thereof,and that designing the circuitry and/or writing the code for thesoftware and/or firmware would be well within the capabilities of one ofskill in the art in light of this disclosure. In addition, those skilledin the art will appreciate that certain mechanisms of the subject matterdescribed herein are capable of being distributed as a program productin a variety of forms, and that an illustrative embodiment of thesubject matter described herein applies equally regardless of theparticular type of signal bearing media used to actually carry out thedistribution. Examples of a signal bearing media include, but are notlimited to, the following: recordable type media such as floppy disks,hard disk drives, CD ROMs, digital tape, and computer memory; andtransmission type media such as digital and analog communication linksusing TDM or IP based communication links (e.g., links carryingpacketized data).

In a general sense, those skilled in the art will recognize that thevarious aspects described herein which can be implemented, individuallyand/or collectively, by a wide range of hardware, software, firmware, orany combination thereof can be viewed as being composed of various typesof “electrical circuitry.” Consequently, as used herein “electricalcircuitry” includes, but is not limited to, electrical circuitry havingat least one discrete electrical circuit, electrical circuitry having atleast one integrated circuit, electrical circuitry having at least oneapplication specific integrated circuit, electrical circuitry forming ageneral purpose computing device configured by a computer program (e.g.,a general purpose computer configured by a computer program which atleast partially carries out processes and/or devices described herein,or a microprocessor configured by a computer program which at leastpartially carries out processes and/or devices described herein),electrical circuitry forming a memory device (e.g., forms of randomaccess memory), and/or electrical circuitry forming a communicationsdevice (e.g., a modem, communications switch, or optical-electricalequipment).

Those skilled in the art will recognize that it is common within the artto describe devices for detection or sensing, signal processing, anddevice control in the fashion set forth herein, and thereafter usestandard engineering practices to integrate such described devicesand/or processes into osmotic pump systems as exemplified herein. Thatis, at least a portion of the devices and/or processes described hereincan be integrated into an osmotic pump system via a reasonable amount ofexperimentation.

Those having skill in the art will recognize that systems as describedherein may include one or more of a memory such as volatile andnon-volatile memory, processors such as microprocessors and digitalsignal processors, computational-supporting or -associated entities suchas operating systems, user interfaces, drivers, sensors, actuators,applications programs, one or more interaction devices, such as dataports, control systems including feedback loops and control implementingactuators (e.g., devices for sensing osmolality, pH, pressure,temperature, or chemical concentration, signal generators for generatingelectromagnetic control signals). A system may be implemented utilizingany suitable available components, combined with standard engineeringpractices.

The foregoing-described aspects depict different components containedwithin, or connected with, different other components. It is to beunderstood that such depicted architectures are merely exemplary, andthat in fact many other architectures can be implemented which achievethe same functionality. In a conceptual sense, any arrangement ofcomponents to achieve the same functionality is effectively “associated”such that the desired functionality is achieved. Hence, any twocomponents herein combined to achieve a particular functionality can beseen as “associated with” each other such that the desired functionalityis achieved, irrespective of architectures or intermediate components.Likewise, any two components so associated can also be viewed as being“operably connected”, or “operably coupled”, to each other to achievethe desired functionality.

While particular aspects of the present subject matter described hereinhave been shown and described, it will be obvious to those skilled inthe art that, based upon the teachings herein, changes and modificationsmay be made without departing from this subject matter described hereinand its broader aspects and, therefore, the appended claims are toencompass within their scope all such changes and modifications as arewithin the true spirit and scope of this subject matter describedherein. Furthermore, it is to be understood that the invention isdefined by the appended claims. It will be understood by those withinthe art that, in general, terms used herein, and especially in theappended claims (e.g., bodies of the appended claims) are generallyintended as “open” terms (e.g., the term “including” should beinterpreted as “including but not limited to,” the term “having” shouldbe interpreted as “having at least,” the term “includes” should beinterpreted as “includes but is not limited to,” etc.). It will befurther understood by those within the art that if a specific number ofan introduced claim recitation is intended, such an intent will beexplicitly recited in the claim, and in the absence of such recitationno such intent is present. For example, as an aid to understanding, thefollowing appended claims may contain usage of the introductory phrases“at least one” and “one or more” to introduce claim recitations.However, the use of such phrases should NOT be construed to imply thatthe introduction of a claim recitation by the indefinite articles “a” or“an” limits any particular claim containing such introduced claimrecitation to inventions containing only one such recitation, even whenthe same claim includes the introductory phrases “one or more” or “atleast one” and indefinite articles such as “a” or “an” (e.g., “a” and/or“an” should typically be interpreted to mean “at least one” and/or “oneor more”); the same holds true for the use of definite articles used tointroduce claim recitations. In addition, even if a specific number ofan introduced claim recitation is explicitly recited, those skilled inthe art will recognize that such recitation should typically beinterpreted to mean at least the recited number (e.g., the barerecitation of “two recitations,” without other modifiers, typicallymeans at least two recitations, or two or more recitations).Furthermore, in those instances where a convention analogous to “atleast one of A, B, and C, etc.” is used, in general such a constructionis intended in the sense of one having skill in the art would understandthe convention (e.g., “a system having at least one of A, B, and C”would include but not be limited to systems that have A alone, B alone,C alone, A and B together, A and C together, B and C together, and/or A,B, and C together). In those instances where a convention analogous to“at least one of A, B, or C, etc.” is used, in general such aconstruction is intended in the sense of one having skill in the artwould understand the convention (e.g., “a system having at least one ofA, B, or C” would include but not be limited to systems that have Aalone, B alone, C alone, A and B together, A and C together, B and Ctogether, and/or A, B, and C together).

Although the methods, devices, systems and approaches herein have beendescribed with reference to certain preferred embodiments, otherembodiments are possible. As illustrated by the foregoing examples,various choices of remote controller, system configuration and osmoticpump device may be within the scope of the invention. As has beendiscussed, the choice of system configuration may depend on the intendedapplication of the system, the environment in which the system is used,cost, personal preference or other factors. System design, manufacture,and control processes may be modified to take into account choices ofuse environment and intended application, and such modifications, asknown to those of skill in the arts device design and construction, mayfall within the scope of the invention. Therefore, the full spirit orscope of the invention is defined by the appended claims and is not tobe limited to the specific embodiments described herein.

1. An osmotic pump system comprising: a delivery reservoir capable ofcontaining a delivery fluid; an osmotic chamber; an osmoticpressure-generating material contained within the osmotic chamber; apressure-responsive movable barrier separating the osmotic chamber fromthe delivery reservoir, the pressure-responsive barrier beingsubstantially impermeable to the osmotic pressure-generating materialand configured to move in response to a change in pressure in theosmotic chamber to produce a change in at least one of pressure orvolume in the delivery reservoir; a semi-permeable membrane separatingthe osmotic chamber from an osmotic fluid source, the semi-permeablemembrane being substantially permeable by fluid from the osmotic fluidsource but substantially impermeable to the osmotic pressure-generatingmaterial; at least one remotely controllable valve configured toregulate the pumping of the delivery fluid from the delivery reservoirresponsive to a time-varying electromagnetic field control signal; and afluid-handling structure located downstream of the delivery reservoirand configured to receive the delivery fluid from the deliveryreservoir.
 2. The osmotic pump system of claim 1, wherein the remotelycontrollable valve is located between the osmotic fluid source and theosmotic chamber to regulate the flow of osmotic fluid into the osmoticchamber.
 3. The osmotic pump system of claim 1, wherein the remotelycontrollable valve is located downstream of the delivery reservoir toregulate the flow of delivery fluid out of the delivery reservoir andinto the downstream fluid-handling structure.
 4. The osmotic pump systemof claim 1, wherein the downstream fluid-handling structure includes achamber.
 5. The osmotic pump system of claim 4, wherein the chamber is areaction chamber.
 6. The osmotic pump system of claim 1, wherein thedownstream fluid-handling structure includes a channel. 7.-26.(canceled)
 27. The osmotic pump system of claim 1, wherein the remotelycontrollable valve includes a bimetallic structure.
 28. The osmotic pumpsystem of claim 1, wherein the remotely controllable valve includes ashape memory material.
 29. The osmotic pump system of claim 28, whereinthe shape memory material is a shape memory metal.
 30. The osmotic pumpsystem of claim 28, wherein the shape memory material is a shape memorypolymer.
 31. The osmotic pump system of claim 1, wherein the remotelycontrollable valve includes an expandable gel structure.
 32. The osmoticpump system of claim 1, wherein the remotely controllable valve includesa ferroelectric material.
 33. The osmotic pump system of claim 1,wherein the remotely controllable valve includes a composite structure.34. The osmotic pump system of claim 1, wherein the remotelycontrollable valve is responsive to a time-varying radio frequencyelectromagnetic field control signal.
 35. The osmotic pump system ofclaim 1, wherein the remotely controllable valve is responsive to atime-varying microwave frequency electromagnetic field control signal.36. The osmotic pump system of claim 1, wherein the remotelycontrollable valve is responsive to a time-varying infraredelectromagnetic field control signal.
 37. The osmotic pump system ofclaim 1, wherein the remotely controllable valve is responsive to atime-varying millimeter wave electromagnetic field control signal. 38.The osmotic pump system of claim 1, wherein the remotely controllablevalve is responsive to a time-varying optical control signal.
 39. Theosmotic pump system of claim 1, wherein the remotely controllable valveis responsive to a time-varying ultraviolet control signal.
 40. Theosmotic pump system of claim 1, wherein the remotely controllable valveis responsive to the time-varying electromagnetic control signal byheating.
 41. The osmotic pump system of claim 1, wherein the remotelycontrollable valve is responsive to the time-varying electromagneticcontrol signal by a change in shape.
 42. The osmotic pump system ofclaim 1, wherein the remotely controllable valve is responsive to thetime-varying electromagnetic control signal by a change in dimension.43. The osmotic pump system of claim 1, wherein the remotelycontrollable valve is responsive to the time-varying electromagneticcontrol signal by a change in configuration.
 44. The osmotic pump systemof claim 1, wherein the remotely controllable valve is responsive to atime-varying electromagnetic control signal by a change in volume.